CFR section
21 CFR 507.202(a): General requirements applying to records
PART 507-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS · Subpart F-Requirements Applying to Records That Must Be Established and Maintained
Key facts
| Citation | 21 CFR 507.202(a) |
|---|---|
| Section | General requirements applying to records |
| Part | PART 507-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS |
| Subpart | Subpart F-Requirements Applying to Records That Must Be Established and Maintained |
| Subchapter | 21 CFR E Drugs Animal |
| Product types cited | Drugs, General, Veterinary |
| Regulation text (excerpt) | (a) Records must: (1) Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records; (2) Contain the actual values and observations obtained during monitoring and as appropriate, during verification activities; (3) Be accurate, indelible, and legible; (4) Be created concurrently with performance of the activity documented; and (5) Be as detailed as necessary to… |
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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.