21 CFR 211.80: General requirements
Requires manufacturers to follow written procedures for receiving, identifying, storing, sampling, testing, and approving or rejecting components, containers, and closures, store them off the floor to prevent contamination, and label each lot with a unique code and status.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart E, Control of Components and Drug Product Containers and Closures
4%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.80, from the 483s we hold.
There was a failure to handle and store components at all times in a manner to prevent contamination.Most used
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures.211.80(a)
Each lot of components was not appropriately identified as to its status in terms of being quarantined, approved or rejected.211.80(d)
Cited over time
483s citing 211.80, by yearMost citations in 2017. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2017.
Recent 483s citing 211.80
- Houston Rx LLC · Houston, TexasYour firm is not storing active pharmaceutical ingredients (API) per the labeled… Aug 28, 2026
- Jubilant HollisterStier LLC · Spokane, WashingtonWritten procedures are not followed for the storage of components… Jun 17, 2026
- Bausch and Lomb Incorporated · Tampa, FloridaWritten procedures are not followed for the receipt, storage and handling of… Mar 20, 2026
- Isorx Cyclotron Center · Lubbock, TexasYou did not establish written procedures describing the identification of… Mar 13, 2026
- Delta Kozmetik Sanayi Ve Ticaret-Selim · Tuzla, Istanbul, TurkeyEach lot of components and closures was not appropriately identified as to its… Mar 5, 2026
The regulation text
§ 211.80 General requirements.
(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).
Questions
What does 21 CFR 211.80 require?
Requires manufacturers to follow written procedures for receiving, identifying, storing, sampling, testing, and approving or rejecting components, containers, and closures, store them off the floor to prevent contamination, and label each lot with a unique code and status.
How often is 211.80 cited in Form 483s?
It appears in about 4% of the drug-manufacturing 483s we hold from 2023 onward.
How do FDA investigators word a 211.80 observation?
The most common opening is: “There was a failure to handle and store components at all times in a manner to prevent contamination.”
Which sections are cited alongside 211.80?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.67 (Equipment cleaning and maintenance), 211.100 (Written procedures; deviations), 211.160 (General requirements).