CFR section
21 CFR 58.195(h): Retention of records
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart J-Records and Reports
Key facts
| Citation | 21 CFR 58.195(h) |
|---|---|
| Section | Retention of records |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart J-Records and Reports |
| Subchapter | 21 CFR A General |
| Product types cited | General |
| Regulation text (excerpt) | (h) If a facility conducting nonclinical testing goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The Food and Drug Administration shall be notified in writing of such a transfer. |
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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.