Food Safety or HACCP Plans

Food Safety Plans. We develop and implement food safety plans tailored to our customers processes and products, helping them comply with current FDA FSMA requirements.
HACCP Plans. USDA regulations and some products under FDA regulations (Seafood, Juice, etc) require the development and implementation of a HACCP Plan. We evaluate our customers processes and design their HACCP Plan in a way that they comply with these requirements with an easy to follow and cost effective approach.

Food Safety or HACCP Plans

Food Safety Plans. We develop and implement food safety plans tailored to our customers processes and products, helping them comply with current FDA FSMA requirements.
HACCP Plans. USDA regulations and some products under FDA regulations (Seafood, Juice, etc) require the development and implementation of a HACCP Plan. We evaluate our customers processes and design their HACCP Plan in a way that they comply with these requirements with an easy to follow and cost effective approach.

GFSI Certification

With increasing complexity in regulations, more and more retailers and customers are requiring producers and manufacturers  to be certified under a Global Food Safety Initiative (GFSI) accredited scheme such as SQF, IFS and BRC. EMCOS specializes in the development of the documentation and in the implementation of the procedures required to obtain these certifications. Our vast experience will help your company obtain this certification in an efficient way, saving time and resources.

GFSI Certification

With increasing complexity in regulations, more and more retailers and customers are requiring producers and manufacturers  to be certified under a Global Food Safety Initiative (GFSI) accredited scheme such as SQF, IFS and BRC. EMCOS specializes in the development of the documentation and in the implementation of the procedures required to obtain these certifications. Our vast experience will help your company obtain this certification in an efficient way, saving time and resources.

Foreign Supplier Verification Program (FSVP)

As part of FSMA requirements,  importers of some food products into the US, are required to develop and implement a Foreign Supplier  Verification Program (FSVP) to guarantee all products are manufactured under FDA’s applicable regulations. EMCOS  helps food importers create their FSVP  by analyzing hazards associated to the products and verifying measures implemented by the foreign supplier to control these hazards.

Foreign Supplier Verification Program (FSVP)

As part of FSMA requirements,  importers of some food products into the US, are required to develop and implement a Foreign Supplier  Verification Program (FSVP) to guarantee all products are manufactured under FDA’s applicable regulations. EMCOS  helps food importers create their FSVP  by analyzing hazards associated to the products and verifying measures implemented by the foreign supplier to control these hazards.

Nutritional Facts and Label review

The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA’s jurisdiction. EMCOS Inc can help you comply with applicable label regulations through the review of the label claims and through the development of the nutritional facts.

Nutritional Facts and Label review

The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA’s jurisdiction. EMCOS Inc can help you comply with applicable label regulations through the review of the label claims and through the development of the nutritional facts.

Gluten Free and Non-GMO Certification

Gluten Free Certification. If a company is aiming to obtain Gluten Free Certification, their products must be free of risk of contamination from any gluten source throughout the entire operation. EMCOS analyzes the company’s entire facility, process and supply chain and develops a series of programs and procedures needed to comply with Gluten Free Certification bodies requirements.
Non-GMO Certification. EMCOS can help you verify your products under the Non-GMO project verification standards by guiding you through the entire process and obtaining final verification marks for applicable products.

Gluten Free and Non-GMO Certification

Gluten Free Certification. If a company is aiming to obtain Gluten Free Certification, their products must be free of risk of contamination from any gluten source throughout the entire operation. EMCOS analyzes the company’s entire facility, process and supply chain and develops a series of programs and procedures needed to comply with Gluten Free Certification bodies requirements.
Non-GMO Certification. EMCOS can help you verify your products under the Non-GMO project verification standards by guiding you through the entire process and obtaining final verification marks for applicable products.

Trainings

EMCOS Lead Instructors have been trained by the Food Safety Preventive Controls Alliance (FSPCA) to teach the following FDA standardized curriculum training programs:

  • Preventive Controls for Human Foods (full training). This three day course will give the trainee the tools necessary to develop a Food Safety Plan and become a Preventive Controls Qualified Individual (PCQI) as required by FDA regulation for food manufacturing facilities.
  • Preventive Controls for Human Foods (blended course part 2). This blended course allows the individual to become a PCQI by completing an online training program followed by an instructor led one-day training session.
  • Foreign Supplier Verification Program (FSVP). This course will allow participants to develop the FSVP and implement applicable requirements  for importers of foods for humans and animals required under FDA regulations.

Trainings

EMCOS Lead Instructors have been trained by the Food Safety Preventive Controls Alliance (FSPCA) to teach the following FDA standardized curriculum training programs:

  • Preventive Controls for Human Foods (full training). This three day course will give the trainee the tools necessary to develop a Food Safety Plan and become a Preventive Controls Qualified Individual (PCQI) as required by FDA regulation for food manufacturing facilities.
  • Preventive Controls for Human Foods (blended course part 2). This blended course allows the individual to become a PCQI by completing an online training program followed by an instructor led one-day training session.
  • Foreign Supplier Verification Program (FSVP). This course will allow participants to develop the FSVP and implement applicable requirements  for importers of foods for humans and animals required under FDA regulations.

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U.S. Agent Services
Terms and Conditions

AGREEMENT by and between Emcos Inc., (“Agent”) and Your Company (“Registrant”).

The parties agree that Agent shall serve as Registrant’s designated U.S. Agent pursuant to section 415(a) of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. sec. 350(d)(a) (the “Act”), subject to the following terms and conditions:

Registrant authorizes Agent’s individual employees to register its food facility (identified above or on the accompanying Emcos Inc. registration form) with the U.S. Food and Drug Administration (“FDA”) pursuant to section 415(a) of the Act and to update or renew such registration or information, during the term hereof, pursuant to 21 C.F.R. Sec. 1.225 et seq. Registrant authorizes Agent’s individual employees to verify that a new registration’s submission was authorized by the owner, operator, or agent in charge of the facility pursuant to 21 C.F.R. 1.231(4), by submitting the electronic “receipt code” in FDA’s Food Facility Registration Module. Registrant consents to inspection by FDA and authorizes Agent to consent to inspection of the facility by FDA and to such other conditions as are required by FDA for facility registration. Registrant represents and warrants that it is the owner, operator or agent in charge of the identified facility, and is responsible for compliance pursuant to 21 C.F.R sec. 1.225 et seq. Registrant will provide Agent with all information and materials necessary or reasonably requested by Agent to register the food facility and to fulfill Agent’s responsibility as U.S. Agent pursuant to the Act. In the event that Registrant provides e-mail or other written communication modifying or supplementing the Legal Company Name and Company Address identified above, such information may be relied upon by Agent and shall be incorporated herein by reference. Registrant warrants that the information and materials provided by Registrant will be accurate, truthful, genuine and current. Agent will forward all communications from the FDA to Registrant at the address, telephone number or email address stated above. Agent may (but is not required to) cancel Registrant’s food facility registration in the event that Registrant fails to respond to communications from Agent or fails to designate a replacement U.S. Agent within ten days of notification by Agent to Registrant that Agent intends to resign as Registrant’s U.S. Agent under the Act.
The services performed by Agent under this agreement are limited to those required to be performed by Agent pursuant to the Act. Agent’s fee shall be paid in accordance with Agent’s standard fee schedule and any modifications or revisions thereto. Agent may perform additional services in its discretion at Registrant’s request for additional fees. Agent does not and will not practice law or render legal advice.
Registrant agrees to reimburse, indemnify and hold harmless Agent from and against any and all expenses, costs and claims, including claims by third parties and nonparties, including but not limited to any governmental agencies, and related costs and attorneys’ fees, and including but not limited to any reinspection fees owed to FDA, whether such claims are alleged in tort, contract or under other law, arising out of or in connection with this agreement, the transactions contemplated hereby, any claim connected to the business or operations of Registrant, or any breach of law by Registrant. Registrant waives any and all claims against Agent arising out of or in connection with this Agreement except for willful misconduct or gross negligence and for those waives its claims to the extent the law permits. As used in this agreement, “Agent” shall include Emcos Inc., its successors, assigns, affiliates, parents, subsidiaries, officers, directors, shareholders, agents and employees. In the event that the FDA notifies Registrant or Agent or both that FDA intends to conduct a reinspection of Registrant’s facility, Registrant shall pay to Agent in advance of such inspection a deposit, or secure a bond, in such amount as is reasonably requested by Agent to pay for anticipated reinspection fees to be charged by FDA or otherwise to be incurred or obligated by Agent in connection with or arising out of such reinspection, and Registrant shall pay immediately any deficiency in such deposit or bond resulting from fees charged by FDA or other expenses incurred by Agent in connection therewith.
Neither party to this contract shall be held responsible for breach of contract caused by an act of God, insurrection, civil war, war, military operation, terrorism or local emergency. Time shall not be of the essence for services to be rendered by Agent. This document, together with the documents incorporated herein by reference, contains the entire agreement between the parties, and may not be modified except in writing signed by the party to be charged. The use of the plural herein includes the singular and vice versa. This agreement shall be construed, and the legal relations between the parties determined, in accordance with the laws of the State of Florida, without giving effect to its choice of law provisions. Any action or proceeding arising out of or in connection with this agreement or the transactions contemplated hereby shall be brought in the courts of Florida in the United States of America. The parties hereto consent to exercise of in personam and subject matter jurisdiction by the courts of the State of Florida.

Agent may terminate this Agreement at any time upon giving written notice to Registrant by U.S. Mail to the address stated above or provided by Registrant for its food facility registration, or by fax to the fax number provided by Registrant for its food facility registration, or by e-mail to the e-mail address provided by Registrant for its food facility registration. Registrant may cancel this Agreement at any time by FedEx, DHL, or UPS overnight delivery service, or by fax to the address and fax number stated above, or found on the website www.emcosinc.com at the time of the cancellation, with such information as will confirm that Registrant’s food facility registration has been maintained or canceled consistent with the requirements of the Act. In the event of termination by either party, no part of the fees paid to Agent hereunder shall be refunded, and the last sentence of paragraph 1 shall survive termination and remain in effect.
This agreement shall expire on December 31, 2020, unless terminated earlier, except for the last sentence of paragraph 1, which shall survive termination. Commencing January 1, 2021, this agreement will renew automatically for successive terms of one year unless terminated pursuant to the terms hereof.
Registrant acknowledges that Emcos Inc. is a private registration agent not affiliated with the U.S. Food and Drug Administration.

FDA Certificate of Registration
Terms and Conditions

AGREEMENT by and between Emcos Inc. and Your Company (“Registrant”)

 

The parties agree that Emcos Inc. shall review registration status of  Registrant’s food facilities with the U.S. Food and Drug Administration (“FDA”) pursuant to section 415(a) of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. sec. 350(d)(a) (the “Act”), subject to the following terms and conditions:

 

Registrant authorizes Emcos Inc.’s individual employees to review registration status of its food facilities (identified above or on the accompanying Emcos Inc. payment form) with FDA pursuant to section 415(a) of the Act. Registrant represents and warrants that it is the owner, operator or agent in charge of the identified facility and is responsible for compliance pursuant to 21 C.F.R sec. 1.225 et seq. Registrant will provide Emcos Inc. with all information and materials necessary or reasonably requested by Emcos Inc. to review the registration status of the food facilities pursuant to the Act. Registrant warrants that the information and materials provided by Registrant will be accurate, truthful, genuine and current. Emcos Inc. will issue a certificate confirming the company was registered in the event registration is up to date on the FDA database. If registration is not up to date or does not exist in the database, Emcos Inc. will notify the customer.

The services performed by Emcos Inc. under this agreement are limited to those required to register Registrant. Emcos Inc.’s fee shall be paid in accordance with Emcos Inc.’s standard fee schedule and any modifications or revisions thereto. Emcos Inc. may perform additional services in its discretion at Registrant’s request for additional fees. Emcos Inc. does not and will not practice law or render legal advice.

Registrant agrees to reimburse, indemnify and hold harmless Emcos Inc. from and against any and all expenses, costs and claims, including claims by third parties and nonparties, including but not limited to any governmental agencies, and related costs and attorneys’ fees, and including but not limited to any reinspection fees owed to FDA, whether such claims are alleged in tort, contract or under other law, arising out or in connection with this agreement, the transactions contemplated hereby, any claim connected to the business or operations of Registrant, or any breach of law by Registrant. Registrant waives any and all claims against Emcos Inc. arising out of or in connection with this Agreement except for willful misconduct or gross negligence and for those waives its claims to the extent the law permits. As used in this agreement, “Emcos Inc.” shall include its successors, assigns, affiliates, parents, subsidiaries, officers, directors, shareholders, agents and employees.

Neither party to this contract shall be held responsible for breach of contract caused by an act of God, insurrection, civil war, war, military operation, terrorism or local emergency. Time shall not be of the essence for services to be rendered by Agent. This document, together with the documents incorporated herein by reference, contains the entire agreement between the parties, and may not be modified except in writing signed by the party to be charged. The use of the plural herein includes the singular and vice versa. This agreement shall be construed, and the legal relations between the parties determined, in accordance with the laws of the State of Florida, without giving effect to its choice of law provisions. Any action or proceeding arising out of or in connection with this agreement or the transactions contemplated hereby shall be brought in the courts of Florida or the U.S. District Courts for the same. The parties hereto consent to exercise of in personam and subject matter jurisdiction by the courts of the State of Florida, and the U.S. District Courts for the same.

Emcos Inc. may terminate this Agreement at any time upon giving written notice to Registrant by U.S. Mail to the address stated above or provided by Registrant for its food facility registrations, or by fax to the fax number provided by Registrant for its food facility registrations, or by e-mail to the e-mail address provided by Registrant for its food facility registrations. Registrant may cancel this Agreement at any time by Federal Express, DHL, or UPS overnight delivery service, with such information as will confirm that Registrant’s food facility registrations have been maintained or canceled consistent with the requirements of the Act. In the event of termination by either party, no part of the fees paid to Agent hereunder shall be refunded.

 

 

FDA Facility Registration
Terms and Conditions

AGREEMENT by and between Emcos Inc. and Your Company (“Registrant”)

The parties agree that Emcos Inc. shall register Registrant’s food facilities with the U.S. Food and Drug Administration (“FDA”) pursuant to section 415(a) of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. sec. 350(d)(a) (the “Act”), subject to the following terms and conditions:

Registrant authorizes Emcos Inc.’s individual employees to register its food facilities (identified above or on the accompanying Emcos Inc. payment form) with FDA pursuant to section 415(a) of the Act and to update or renew such registration or information, during the term hereof, pursuant to 21 C.F.R. sec. 1.225 et seq. Registrant authorizes Agent’s individual employees to verify that a new registration’s submission was authorized by the owner, operator, or agent in charge of the facility pursuant to 21 C.F.R. 1.231(4), by submitting the electronic “receipt code” in FDA’s Food Facility Registration Module and to consent on Registrant’s behalf to inspection of the facility by FDA and to such other conditions as are required by FDA for facility registration. Registrant represents and warrants that it is the owner, operator or agent in charge of the identified facility and is responsible for compliance pursuant to 21 C.F.R sec. 1.225 et seq. Registrant will provide Emcos Inc. with all information and materials necessary or reasonably requested by Emcos Inc. to register or renew the food facilities pursuant to the Act. Registrant warrants that the information and materials provided by Registrant will be accurate, truthful, genuine and current. Emcos Inc. will forward all communications from FDA to Registrant at the address, telephone number or email address stated above.

The services performed by Emcos Inc. under this agreement are limited to those required to register Registrant. Emcos Inc.’s fee shall be paid in accordance with Emcos Inc.’s standard fee schedule and any modifications or revisions thereto. Emcos Inc. may perform additional services in its discretion at Registrant’s request for additional fees. Emcos Inc. does not and will not practice law or render legal advice.

Registrant agrees to reimburse, indemnify and hold harmless Emcos Inc. from and against any and all expenses, costs and claims, including claims by third parties and nonparties, including but not limited to any governmental agencies, and related costs and attorneys’ fees, and including but not limited to any reinspection fees owed to FDA, whether such claims are alleged in tort, contract or under other law, arising out or in connection with this agreement, the transactions contemplated hereby, any claim connected to the business or operations of Registrant, or any breach of law by Registrant. Registrant waives any and all claims against Emcos Inc. arising out of or in connection with this Agreement except for willful misconduct or gross negligence and for those waives its claims to the extent the law permits. As used in this agreement, “Emcos Inc.” shall include its successors, assigns, affiliates, parents, subsidiaries, officers, directors, shareholders, agents and employees.

Neither party to this contract shall be held responsible for breach of contract caused by an act of God, insurrection, civil war, war, military operation, terrorism or local emergency. Time shall not be of the essence for services to be rendered by Agent. This document, together with the documents incorporated herein by reference, contains the entire agreement between the parties, and may not be modified except in writing signed by the party to be charged. The use of the plural herein includes the singular and vice versa. This agreement shall be construed, and the legal relations between the parties determined, in accordance with the laws of the State of Florida, without giving effect to its choice of law provisions. Any action or proceeding arising out of or in connection with this agreement or the transactions contemplated hereby shall be brought in the courts of Florida or the U.S. District Courts for the same. The parties hereto consent to exercise of in personam and subject matter jurisdiction by the courts of the State of Florida, and the U.S. District Courts for the same.

Emcos Inc. may terminate this Agreement at any time upon giving written notice to Registrant by U.S. Mail to the address stated above or provided by Registrant for its food facility registrations, or by fax to the fax number provided by Registrant for its food facility registrations, or by e-mail to the e-mail address provided by Registrant for its food facility registrations. Registrant may cancel this Agreement at any time by Federal Express, DHL, or UPS overnight delivery service, with such information as will confirm that Registrant’s food facility registrations have been maintained or canceled consistent with the requirements of the Act. In the event of termination by either party, no part of the fees paid to Agent hereunder shall be refunded.

This agreement shall expire on December 31, 2020, unless terminated earlier. Commencing January 1, 2021, this agreement will renew automatically for successive terms of one year unless terminated pursuant to the terms hereof.

Options for FDA Registration

FDA Certificate of Registration. Select this option if our company is already registered with the FDA and you wish to obtain a certificate confirming your company is up to date and registered. You must provide us with the FDA registration number and PIN, previously on the form.


FDA Facility Registration and Certificate of Registration. Select this option if your company is not currently registered with the FDA and you wish to become registered and obtain a Certificate of Registration.


US Agent Only. Select this option if you are already registered with the FDA and want us to represent your company as US Agents in the United States of America. Per the FD&C Act “Every foreign facility must have a U.S. Agent who acts as the domestic communications representative for that facility”. See more information.


FDA Registration, Certificate and US Agent. Select this option if your company is not currently registered with the FDA and you wish to register, obtain a certificate of registration and contract our services as US Agents in the Unites States of America.