CFR section
21 CFR 58.185(c): Reporting of nonclinical laboratory study results
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart J-Records and Reports
Key facts
| Citation | 21 CFR 58.185(c) |
|---|---|
| Section | Reporting of nonclinical laboratory study results |
| 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) | (c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible. |
At a glance
- 1–9 Inspections citing this section
- 1–9 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.