APR Nov/Dec 2022 - 55

« MANUFACTURING
inspection readiness, including identifying the best subject matter
experts for potential interactions with an investigator.
References
1.
2.
3.
4.
5.
6.
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Id.
Supra Note 2.
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21 U.S.C. § 374(a)(1).
Id.
The Federal Food, Drug, and Cosmetic Act (the " Act " ) states that a drug not made in
accordance with cGMP is deemed " adulterated. " The Act goes on to say that the cGMP
regulations are " to assure that such drug meets the requirements of this Act as to safety
and has the identity and strength, and meets the quality and purity characteristics, which
it purports or is represented to possess. " Food, Drug, and Cosmetic Act Section 501(a)(2)(B).
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The FDA has also piloted other inspectional initiatives such as sampling and testing
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been postponed. United States Government Accountability Office, DRUG SAFETY: FDA's
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www.americanpharmaceuticalreview.com |
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FDA, FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect
Public Health (July 22, 2022).
FDA, Guidance for Industry: Remote Interactive Evaluations of Drug Manufacturing and
Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (April
2021).
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APR Nov/Dec 2022

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