21 CFR 820.60
Identification
21 CFR 820.60 is the regulation titled “Identification” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 3 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
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 820.100, in 2 letters
- Closed out
- 33% 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 820.60 most often, as written in the letters.
- 1 letterFailure to adequately establish procedures for identifying product during all stages of receipt, production, distribution, and installation, as required by 21 CFR 820.60
The regulation
Read the text of 21 CFR 820.60 (eCFR, as of Jun 1, 2025)
Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.60.
- 21 CFR 820.100Corrective and preventive action2 letters cite both
- 21 CFR 820.186Quality system record2 letters cite both
- 21 CFR 820.198Complaint files2 letters cite both
- 21 CFR 820.30Design controls2 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
Latest letters citing it
The 3 letters citing 21 CFR 820.60 that FDA posted most recently.
- DevicesView Hong Qiangxing Shenzhen Electronics LimitedWrist blood pressure monitors, TENS and PMS devicesIssuedOct 28, 2025PostedNov 25, 2025
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
- DevicesView W.H.P.M, Inc.COVID-19 Test KitsIssuedJun 30, 2022PostedJul 12, 2022
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Counts include every citation in a letter, as the Letters filter does. How this database is built.