Description
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) was signed into law. Section 707 of FDASIA added section 501(j) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to deem adulterated a drug that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” Section 707(b) of FDASIA required the Food and Drug Administration (FDA) to issue guidance that defined the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j).
Scope & Applicability
Product Classes
4Defined in section 201(g) of the FD&C Act; Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; Product classification based on chemical action or specific intended uses like altering pH
Defined in section 201(h) of the FD&C Act; Instrument or apparatus which does not achieve primary purpose through chemical action; Product classification based on primary intended purpose and chemical action
Subject to inspection authority
Subject to inspection authority
Stakeholders
6Authorized representative conducting the inspection
Person whose actions may cause a product to be deemed adulterated
Person whose actions may cause a product to be deemed adulterated
Person whose actions may cause a product to be deemed adulterated
Facilities compounding drug products pursuant to section 503B.
Representative of a foreign owner who serves as the FSVP importer; Person in the US acting as a communications link or FSVP representative.; Designated representative for foreign owners; designated representative for foreign owners
Regulatory Context
Attributes
1Standard for providing records to FDA
Related CFR Sections (1)
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Supergoop!
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OTC/Unapproved New Drug/Misbranded
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OTC/Unapproved New Drug/Misbranded
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- 2025-05-27
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Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
- 2025-04-29
Electronic Drug Registration and Listing System (eDRLS)/Violations
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC
- 2025-02-18
CGMP/Finished Pharmaceutical/Adulterated
Jagsonpal Pharmaceuticals Limited
- 2024-10-22
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register
Omni Lens Pvt. Ltd.
- 2024-08-20
Failure to Register and List
Media Networks Sydney Pty Limited
- 2024-04-23
Failure to Register and List
Zen Enterprises LLC
See Also (8)
- Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Status: Final)
- Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for Industry (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)
- Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for Industry (Status: Final)
- Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry (Status: Final)