Frequently Asked Questions (FAQ)

What is the USDA?

The United States Department of Agriculture, also known as the Agriculture Department, is the U.S. federal executive department responsible for developing and executing federal laws related to farming, agriculture, forestry, and food. The USDA provides leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on public policy, the best available science, and effective management.

What is a HACCP Plan?

A Hazard Analysis and Critical Control Point Plan is a program implemented by the USDA’s Food Safety Inspection Service (FSIS) to ensure the wholesomeness of the meat and poultry sold to consumers. Under the preHACCP system, the production of meat and poultry products was monitored at every stage by Government employees rather than by in-plant production managers. The HACCP program reversed this arrangement by allowing a plant to monitor itself. It gave industry, not Government, the primary responsibility for ensuring the safety of meat and poultry products. Industry was required to implement a HACCP system that identified and controlled (1) physical, chemical, and biological hazards to the production process and (2) a program of ongoing microbial testing that served as verification that the system was working.

Who needs a HACCP Plan?

Every meat and poultry plant must perform a hazard analysis to identity the food safety hazards likely to occur in its production process. If your manufacturing plant uses meat or poultry products as raw ingredients or your process meat or poultry products, you must have a HACCP plan in place.

What is the FDA?

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services. It is is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the food supply, cosmetics, and products that emit radiation in the USA.

What is a Food Safety Plan?

As the FDA states: A Food Safety Plan (FSP) consists of the primary documents in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury. It contains a collection of written documents that describes activities that ensure the safety of food during manufacturing, processing, packing, and holding.

 

Who needs a Food Safety Plan?

Facilities registered with the FDA as manufacturing food who identify a hazard on the hazard analysis requiring a preventive control, must have a written food safety plan. Regulations vary depending on plant size and products.

What does PCQI mean?

According to the definitions in the FDA Preventive Controls for Human Food Rule, a PCQI is a qualified individual (QI) who has successfully completed training in the development and application of risk‐based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA.

What does a PCQI do?

A PCQI has the following responsibilities according to 21CFR117:
(1) Preparation of the food safety plan (117.126(a)(2));
(2) Validation of the preventive controls (117.160(b)(1));
(3) Written justification for validation to be performed in a timeframe that exceeds the first 90 calendar days of production of the applicable food;
(4) Determination that validation is not required (117.160(c)(5));
(5) Review of records (117.165(a)(4));
(6) Written justification for review of records of monitoring and corrective actions within a timeframe that exceeds 7 working days;
(7) Reanalysis of the food safety plan (117.170(d)); and
(8) Determination that reanalysis can be completed, and additional preventive controls validated, as appropriate to the nature of the preventive control and its role in the facility’s food safety system, in a timeframe that exceeds the first 90 calendar days of production of the applicable food.

What is GFSI?

GFSI or Global Food Safety Initiative is a non-profit foundation founded to reduce food safety risks, audit duplication and costs while building trust throughout the supply chain. It was founded based on one idea: once certified, recognized everywhere.

How can my company become GFSI certified?

“GFSI certification” does not exist. GFSI does not carry out any accreditation or
certification activities. However, it is possible to achieve certification against one of the GFSI-recognised food safety certification programmes such as SQF, BRCGS, FSSC 22000, IFS, etc.

What certification programme can I obtain?

To decide what is the best certification programme for your facility many variables must be taken into account, including but not limited to: type of business, geographical recognition, customer requirements, etc.

What certification programmes exist?

There are many certification programmes around the world. Some of them are: SQFI (Safe Quality Food Institute), Primus GFS, IFS (International Featured Standard) and BRC (British Retail Consortium).

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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.