CFR section
21 CFR 211.198(b): Complaint files
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart J-Records and Reports
Key facts
| Citation | 21 CFR 211.198(b) |
|---|---|
| Section | Complaint files |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart J-Records and Reports |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility. Written records involving a drug product shall be maintained until at least 1… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.