21 CFR 820.160
Distribution
21 CFR 820.160 is the regulation titled “Distribution” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 6 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
- 6 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 6 letters
- Closed out
- 17% 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 820.160 most often, as written in the letters.
- 1 letterFailure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that…
- 1 letterFailure to establish procedures for control and distribution of finished devices, as required by 21 CFR 820.160(a).** Specifically, your firm does not have procedures for control and distribution of your COVID-19 Test
- 1 letterFailure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a).** Specifically, your firm has not established procedures, instructions, or processes to identify, investigate, and…
The regulation
Read the text of 21 CFR 820.160 (eCFR, as of Jun 1, 2025)
(a) Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Where a device's fitness for use or quality deteriorates over time, the procedures shall ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed.
(b) Each manufacturer shall maintain distribution records which include or refer to the location of:
(1) The name and address of the initial consignee;
(2) The identification and quantity of devices shipped;
(3) The date shipped; and
(4) Any control number(s) used.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.160.
- 21 CFR 820.100Corrective and preventive action6 letters cite both
- 21 CFR 820.198Complaint files6 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?5 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance5 letters cite both
- 21 CFR 820.20Management responsibility4 letters cite both
- 21 CFR 820.30Design controls4 letters cite both
- 21 CFR 820.50Purchasing controls4 letters cite both
- 21 CFR 820.25Personnel3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.160 that FDA posted most recently.
- DevicesView Royal PhilipsEPIQ Elite Ultrasound system, Ultrasound Transducers, IntelliSpace Cardiovascular software, EPIQ C cart ultrasound systemIssuedSep 9, 2025PostedOct 28, 2025
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
- DevicesView North American Diagnostics, LLCCOVID-19 TestIssuedDec 27, 2022PostedApr 18, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.