CFR section
21 CFR 58.35(d): Quality assurance unit
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart B-Organization and Personnel
Key facts
| Citation | 21 CFR 58.35(d) |
|---|---|
| Section | Quality assurance unit |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart B-Organization and Personnel |
| Subchapter | 21 CFR A General |
| Product types cited | General, Veterinary |
| Regulation text (excerpt) | (d) A designated representative of the Food and Drug Administration shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed-up in accordance with this paragraph. |
At a glance
- 1–9 Inspections citing this section
- None Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.