21 CFR 820.160: Distribution
Manufacturers had to maintain procedures ensuring only approved finished devices were distributed, purchase order ambiguities were resolved, expired or deteriorated devices were withheld, and records kept of consignee, quantity, ship date, and control numbers.
Part 820, Quality System Regulation · Subpart L, Handling, Storage, Distribution, and Installation
Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.
How FDA words it
The opening lines investigators use most when they cite 820.160, from the 483s we hold.
Procedures for control and distribution of finished devices have not been established.Most used
Recent 483s citing 820.160
- Variamed, LLC · Chattanooga, TennesseeProcediues for control and distribution of finished devices have not been… Dec 18, 2024
- INNOVA MEDICAL GROUP, INC · Pasadena, CaliforniaProcedures for control and distribution of finished devices have not been… Apr 9, 2021
- Ad-Tech Medical Instrument Corporation · Oak Creek, WisconsinDistribution records were not maintained… Jun 27, 2019
- TERRIFIC CARE LLC · Passaic, New JerseyProcedures for control and distribution of finished devices have not been… Feb 5, 2019
- Organ Recovery Systems, Inc · Itasca, IllinoisProcedures for control and distribution of finished devices have not been… Feb 10, 2017
The regulation text
§ 820.160 Distribution. As published before it was replaced.
(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.
Questions
What does 21 CFR 820.160 require?
Manufacturers had to maintain procedures ensuring only approved finished devices were distributed, purchase order ambiguities were resolved, expired or deteriorated devices were withheld, and records kept of consignee, quantity, ship date, and control numbers.
How do FDA investigators word a 820.160 observation?
The most common opening is: “Procedures for control and distribution of finished devices have not been established.”
Which sections are cited alongside 820.160?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.30 (Design controls), 820.50 (Purchasing controls).