21 CFR 820.86: Acceptance status
Required manufacturers to identify product acceptance status as conforming or nonconforming throughout manufacturing, packaging, labeling, installation, and servicing, so only product that passed required acceptance activities was distributed, used, or installed.
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 820.86, from the 483s we hold.
The acceptance status of product was not identified to indicate conformance or nonconformance with acceptance criteria.Most used
Recent 483s citing 820.86
- Johnson Medtech LLC · Vandalia, OhioThe acceptance status of product was not maintained… Dec 8, 2022
- Prestige Medical · Northridge, CaliforniaThe acceptance status of product was not identified to indicate conformance or… Oct 24, 2019
- Catalent Pharma Solutions, LLC · Woodstock, IllinoisThe acceptance status of product was not maintained… Jul 3, 2018
- Circulatory Technology Inc · Oyster Bay, New YorkThe acceptance status of product was not identified to indicate conformance or… Jul 8, 2016
- American Orthodontics Corporation · Sheboygan, WisconsinThe acceptance status of product was not identified to indicate conformance or… Jun 16, 2016
The regulation text
§ 820.86 Acceptance status. As published before it was replaced.
Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed.
Questions
What does 21 CFR 820.86 require?
Required manufacturers to identify product acceptance status as conforming or nonconforming throughout manufacturing, packaging, labeling, installation, and servicing, so only product that passed required acceptance activities was distributed, used, or installed.
How do FDA investigators word a 820.86 observation?
The most common opening is: “The acceptance status of product was not identified to indicate conformance or nonconformance with acceptance criteria.”
Which sections are cited alongside 820.86?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.20 (Management responsibility), 820.30 (Design controls).