§ 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).

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 211.80

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

• Procedures To Be in Writing 276
• Handling and Storage to Prevent Contamination 148
• Written Procedures Not Followed 136
• Status of Each Lot Identified 67
• Identification of Each Lot in Each Shipment 22
• Disposition recorded by lot identification 11

Warning letters citing § 211.80

14 FDA warning letters since 2017 cite this section ; the most recent:

• AQ USA Inc., d.b.a Ross Healthcare Inc. 12 Feb 2026
• Meds For Vets, LLC 15 Aug 2025
• Re-Gen Active Lab, Inc. 27 May 2022
• Utah Cord Bank LLC dba Utah Cell Bank 10 Aug 2021
• EUCYT Laboratories LLC 4 Jun 2020
• Stemell Inc 28 Aug 2019
• Westlab Pharmacy, Inc. dba Westlab Pharmacy 26 Jun 2019
• Apollo Care 20 Mar 2019
• Genetech, Inc. 29 Nov 2018
• StemGenex Biologic Laboratories, LLC 31 Oct 2018
• American CryoStem Corporation 3 Jan 2018
• RTI Surgical, Inc. 8 Nov 2017

FDA guidance that cites § 211.80

• Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers 9 Oct 2026
• Container Closure Systems for Human Drugs and Biological Products draft 13 Aug 2026
• Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry draft 16 Dec 2021
• Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry draft 29 Sept 2021
• Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency: Guidance for Industry 19 Jan 2021
• 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
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry 4 Oct 2004
• Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry 7 Jul 1999

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978