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21 CFR Part 820 · Quality Management System Regulation

§ 820.150 Storage

Subpart L - Handling, Storage, Official text on eCFR
Removed from 21 CFR. The Quality Management System Regulation (QMSR) replaced the Quality System Regulation on 2 Feb 2026. Removed by the Quality Management System Regulation, effective 2 February 2026: Part 820 now incorporates ISO 13485:2016 by reference (§ 820.7) and requires it in § 820.10. See § 820.10. The text below is the former QSR wording, kept for reference.

(a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate.

(b) Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms.

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 § 820.150

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

  • Lack of or inadequate procedures for storage. 136
  • Storage procedures to prevent mix-ups 17
  • Storage procedures to avoid release of unsuitable product 5
  • Procedures - receipt and dispatch 3
  • Stock rotation, assessment before release 3

Warning letters citing § 820.150

3 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 820.150