21 CFR 820.40: Document controls
Required manufacturers to maintain procedures controlling all quality system documents, including dated, signed approval before issuance, availability at points of use, prompt removal of obsolete versions, and reviewed, approved, communicated, and recorded changes.
Part 820, Quality System Regulation · Subpart D, Document Controls
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 820.40, from the 483s we hold.
Document control procedures have not been adequately established.Most used
Document control procedures have not been established.
Documents were not reviewed and not approved by designated individual(s) prior to issuance.820.40(a)
Cited over time
483s citing 820.40, by yearMost 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 820.40
- Seniorlife Technologies Inc · Bellevue, WashingtonDocuments required by the quality management system have not been controlled… Feb 20, 2026
- Marson Medical, Inc. · New JerseyDocument control procedures have not been adequately established… Jan 16, 2026
- MAVIDON MEDICAL PRODUCTS · Flat Rock, North CarolinaDocument control procedures have not been adequately established… Aug 5, 2025
- Smaart Medical Systems, Inc · Dallas, TexasRecords of changes did not include a description of the change… May 9, 2025
- Quasar Bio-Tech, Inc · Yorba Linda, CaliforniaDocument control procedures have not been maintained… Dec 20, 2024
The regulation text
§ 820.40 Document controls. As published before it was replaced.
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:
(a)Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.
(b)Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.
Questions
What does 21 CFR 820.40 require?
Required manufacturers to maintain procedures controlling all quality system documents, including dated, signed approval before issuance, availability at points of use, prompt removal of obsolete versions, and reviewed, approved, communicated, and recorded changes.
How do FDA investigators word a 820.40 observation?
The most common opening is: “Document control procedures have not been adequately established.”
Which sections are cited alongside 820.40?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.30 (Design controls), 820.50 (Purchasing controls), 820.198 (Complaint files).