Food and Drug Administration
US federal regulator; issues the 21 CFR parts and FDA guidance that set cGMP, data-integrity, and clinical expectations for the US market.
WHAT FDA COVERS
The US Food and Drug Administration regulates drugs, biologics, medical devices, food, cosmetics, and veterinary products under the Federal Food, Drug, and Cosmetic Act, with biologics licensed under section 351 of the Public Health Service Act. Its requirements are codified in Title 21 of the Code of Federal Regulations, and the operational work is split across centres — CDER for drugs, CBER for biologics, CDRH for devices, CFSAN for food and cosmetics, and CVM for veterinary medicine.
WHERE IT SITS INTERNATIONALLY
FDA is a founding regulatory member of ICH and has been a PIC/S participating authority since 2011. It operates a Mutual Recognition Agreement with EU authorities covering GMP inspections of human medicines, which lets each side rely on the other’s inspection outcomes for many product types.
HOW ITS REQUIREMENTS BITE
FDA enforces primarily through inspection. Pre-approval inspections test whether a site can actually make what an application describes; surveillance inspections are routine and risk-scheduled; for-cause inspections follow a signal. An inspection closes with a Form 483 listing observations, which can escalate to a warning letter, and from there to import alert, seizure, injunction, or consent decree. A drug not made in conformity with cGMP is deemed adulterated under §501(a)(2)(B) — the statutory hook behind most enforcement.
WHAT FDA PUBLISHES
- 0121 CFR parts — the binding regulations (210/211 drugs, 820 devices, 58 GLP, 312 INDs, 11 electronic records)
- 02Guidance for Industry — FDA’s current thinking; non-binding, but the practical standard
- 03Form 483 observations and warning letters, both publicly posted
- 04Compliance Program Guidance Manuals and the Investigations Operations Manual used by investigators
- 05Recall and enforcement reports, and the openFDA datasets built from them
WHAT PRACTITIONERS GET WRONG
- ›Guidance is explicitly non-binding — but departing from it means being ready to justify an alternative that achieves the same outcome.
- ›The "c" in cGMP means the bar rises with industry practice; meeting the literal 1978 text of Part 211 is a weak defence.
- ›Warning letters are the best free intelligence available on where FDA is currently focused — read them by theme, not one at a time.
- ›Repeat observations from a prior inspection are treated as evidence the quality system failed to act, and escalate faster.
FDA STANDARDS SPEQ DECODES · 26
DISCIPLINES IN FDA’S REMIT
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