CFR section
21 CFR 111.610(a): What records must be made available to FDA?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart P-Records and Recordkeeping
Key facts
| Citation | 21 CFR 111.610(a) |
|---|---|
| Section | What records must be made available to FDA? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart P-Records and Recordkeeping |
| Subchapter | 21 CFR B Food |
| Product types cited | Devices, Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | (a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested. |
At a glance
- 10–99 Inspections citing this section
- 10–99 Warning letters citing this section
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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.