Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.
21 CFR Part 820 · Quality Management System Regulation
§ 820.140 Handling
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 § 820.140
Form FDA 483 observations citing this section, fiscal years 2009–2025 (Devices).
- Lack of or inadequate procedures for handling 49
Warning letters citing § 820.140
2 FDA warning letters since 2017 cite this section :
- LEVO AG 18 Jul 2025
- USA Medical LLC 3 Aug 2022