21 CFR 820.150
Storage
21 CFR 820.150 is the regulation titled “Storage” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 2 FDA warning letters have cited it.
Part 820 changed when FDA's Quality Management System Regulation took effect on February 2, 2026. This is the earlier text these letters cite.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 820.100, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 820.150 most often, as written in the letters.
- 1 letterFailure to store devices in a manner to facilitate proper stock rotation and to assess its condition as appropriate, as required by 21 CFR 820.150(a). Specifically:
The regulation
Read the text of 21 CFR 820.150 (eCFR, as of Jun 1, 2025)
(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.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.150.
- 21 CFR 820.100Corrective and preventive action2 letters cite both
- 21 CFR 820.75Process validation2 letters cite both
- 21 CFR 820.90Nonconforming product2 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 820.120Device labeling1 letter cites both
- 21 CFR 820.130Device packaging1 letter cites both
- 21 CFR 820.140Handling1 letter cites both
- 21 CFR 820.160Distribution1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 820.150 that FDA posted most recently.
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
- DevicesView Integra LifeSciences Corporationcollagen based medical devices, including DurepairIssuedJul 17, 2023PostedAug 15, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.