FDA Intel

21 CFR 820.80: Receiving, in-process, and finished device acceptance

Manufacturers had to maintain procedures to inspect, test, or verify incoming, in-process, and finished devices, control product until accepted, release only after DMR activities, data review, and dated signed authorization, and record results in the DHR.

Part 820, Quality System Regulation · Subpart H, Acceptance Activities

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 820.80, from the 483s we hold.

Procedures for acceptance of incoming product have not been adequately established.Most used
Procedures for finished device acceptance have not been adequately established.820.80(d)
Procedures for acceptance activities have not been adequately established.820.80(a)

Cited over time

483s citing 820.80, by year

Most citations in 2024. Bars are relative to the busiest year. *2026 to date.

Years shown: 2017 to 2026. The busiest year was 2024.

Recent 483s citing 820.80

See all 483s citing 820.80

The regulation text

§ 820.80 Receiving, in-process, and finished device acceptance. As published before it was replaced.

(a)General. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.

(b)Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.

(c)In-process acceptance activities. Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.

(d)Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:

(1)The activities required in the DMR are completed;

(2)the associated data and documentation is reviewed;

(3)the release is authorized by the signature of a designated individual(s); and

(4)the authorization is dated.

(e)Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include:

(1)The acceptance activities performed;

(2)the dates acceptance activities are performed;

(3)the results;

(4)the signature of the individual(s) conducting the acceptance activities; and

(5)where appropriate the equipment used. These records shall be part of the DHR.

Questions

What does 21 CFR 820.80 require?

Manufacturers had to maintain procedures to inspect, test, or verify incoming, in-process, and finished devices, control product until accepted, release only after DMR activities, data review, and dated signed authorization, and record results in the DHR.

How do FDA investigators word a 820.80 observation?

The most common opening is: “Procedures for acceptance of incoming product have not been adequately established.”

Which sections are cited alongside 820.80?

In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.50 (Purchasing controls), 820.30 (Design controls).