21 CFR 211.80
General requirements
21 CFR 211.80 is the regulation titled “General requirements” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 211.100, in 3 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
Most are biologics letters (2 of 3). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.80 most often, as written in the letters.
- 1 letterFailure to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers…
- 1 letterFailure to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval or rejection of components and drug product containers and…
- 1 letterFailure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR…
The regulation
Read the text of 21 CFR 211.80 (eCFR, as of Sep 1, 2026)
(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.
(b) Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination.
(c) Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection.
(d) Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected).
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.80.
- 21 CFR 211.100Written procedures; deviations3 letters cite both
- 21 CFR 211.166Stability testing3 letters cite both
- 21 CFR 211.188Batch production and control records3 letters cite both
- 21 CFR 1271.10Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?2 letters cite both
- 21 CFR 1271.15Are there any exceptions from the requirements of this part?2 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?2 letters cite both
- 21 CFR 211.113Control of microbiological contamination2 letters cite both
- 21 CFR 211.160General requirements2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.80 that FDA posted most recently.
- DrugsView AQ USA Inc., d.b.a Ross Healthcare Inc.drug productsIssuedFeb 12, 2026PostedFeb 24, 2026
- BiologicsView Re-Gen Active Lab, Inc.ActiveShot™, ActivePro™, and ActiveFlow™IssuedMay 27, 2022PostedJun 28, 2022
- BiologicsView Utah Cord Bank LLC dba Utah Cell Bankcellular products for allogeneic use, including human umbilical cord blood, umbilical cord, and amniotic membrane derived cellular products…IssuedAug 10, 2021PostedAug 17, 2021
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Counts include every citation in a letter, as the Letters filter does. How this database is built.