21 CFR 820.140
Handling
21 CFR 820.140 is the regulation titled “Handling” 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 803.17, in 2 letters
- Closed out
- 50% 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.
The regulation
Read the text of 21 CFR 820.140 (eCFR, as of Jun 1, 2025)
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.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.140.
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2 letters cite both
- 21 CFR 820.100Corrective and preventive action2 letters cite both
- 21 CFR 820.160Distribution2 letters cite both
- 21 CFR 820.198Complaint files2 letters cite both
- 21 CFR 820.20Management responsibility2 letters cite both
- 21 CFR 820.22Quality audit2 letters cite both
- 21 CFR 820.25Personnel2 letters cite both
- 21 CFR 820.50Purchasing controls2 letters cite both
Latest letters citing it
The 2 letters citing 21 CFR 820.140 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 USA Medical LLCSARS-CoV-2 Antigen Rapid Test kitsIssuedAug 3, 2022PostedAug 30, 2022
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Counts include every citation in a letter, as the Letters filter does. How this database is built.