Description
The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
Scope & Applicability
Stakeholders
7Personnel conducting food safety audits under the regulation.
Entities receiving food or facility certificates under the program.
Accredited third-party certification body; CB accredited under TPP
Recognized Accreditation Bodies monitoring accredited Certification Bodies.
Entities receiving food safety audits and certifications
Accredited bodies that conduct food safety audits
Assesses testing laboratories under ASCA Pilot; Entities involved in the ASCA Pilot
Regulatory Context
Attributes
1Requirement that certificates be issued for a term up to 12 months
Identified Hazards
Hazards
1Public health concern causing travel restrictions and impracticability of onsite activities.
Related CFR Sections (5)
- 21CFR1.654§ 1.654 When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
If an accredited third-party certification body has reason to believe that an eligible entity to which it issued a food or facility certification may no longer be in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, the accredited third-party certification Read full regulation →
- 21CFR1.653§ 1.653 What must an accredited third-party certification body do when issuing food or facility certifications?
(a) Basis for issuance of a food or facility certification.Read full regulation →
- 21CFR1.621§ 1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
(a) A recognized accreditation body must annually conduct a comprehensive assessment of the performance of each third-party certification body it accredited under this subpart by reviewing the accredited third-party certification body's self-assessments (including information on compliance with the Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR1.651§ 1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
(a) Audit planning. Before beginning to conduct a food safety audit under this subpart, an accredited third-party certification body must:Read full regulation →
See Also (8)
- Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification Program (Status: Draft)
- Guidance for Industry: FDA's Voluntary Qualified Importer Program (Status: Final)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)
- CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (Status: Final)