§ 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 .

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What FDA inspectors cite under § 211.82

Form FDA 483 observations citing this section, fiscal years 2009–2023 (Drugs).

• Quarantine Storage of Components 37
• Examination on receipt, before acceptance 28

Warning letters citing § 211.82

1 FDA warning letters since 2017 cite this section :

• Dae Young Foods Co., Ltd. 20 Nov 2017

FDA guidance that cites § 211.82

• Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products draft 29 Apr 2024
• Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
• BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978
• 73 FR 51932 8 Sept 2008