21 CFR 211.82: Receipt and storage of untested components, drug product containers, and closures
Requires manufacturers to visually inspect incoming components, containers, and closures for correct labeling, damage or broken seals, and contamination, and to hold them in quarantine until tested or examined and released.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart E, Control of Components and Drug Product Containers and Closures
How FDA words it
The opening lines investigators use most when they cite 211.82, from the 483s we hold.
Incoming components are not stored under quarantine until they have been tested or examined, as appropriate, and released.Most used
Each container or grouping of containers of components is not examined visually upon receipt and before acceptance for appropriate labeling as to contents.211.82(a)
Cited over time
483s citing 211.82, 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 211.82
- Homeocare Laboratories, Inc · Yonkers, New YorkIncoming components are not stored under quarantine until they have been tested or… Feb 21, 2023
- Centrix, Inc · Shelton, ConnecticutEach container or grouping of containers of components is not examined visually… Mar 2, 2022
- Edge Pharma, LLC · Colchester, VermontIncoming components are not stored under quarantine until they have been tested or… Mar 30, 2020
- Henan Kangdi Medical Devices Co. Ltd. · ZHOUKOU, Henan, ChinaFach container or grouping of containers of components is not examined visually… Mar 7, 2019
- Mikart, LLC · Atlanta, GeorgiaIncoming components are not stored under quarantine until they have been tested or… Jan 18, 2019
The regulation text
§ 211.82 Receipt and storage of untested components, drug product containers, and closures.
(a)Upon receipt and before acceptance, each container or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination.
(b)Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, whichever is appropriate, and released. Storage within the area shall conform to the requirements of § 211.80.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
Questions
What does 21 CFR 211.82 require?
Requires manufacturers to visually inspect incoming components, containers, and closures for correct labeling, damage or broken seals, and contamination, and to hold them in quarantine until tested or examined and released.
How do FDA investigators word a 211.82 observation?
The most common opening is: “Incoming components are not stored under quarantine until they have been tested or examined, as appropriate, and released.”
Which sections are cited alongside 211.82?
In the same 483s, investigators most often also cite 211.166 (Stability testing), 211.165 (Testing and release for distribution), 211.192 (Production record review), 211.25 (Personnel qualifications).