FDA Inspection 1038575 — Societal CDMO Gainesville, LLC
The FDA completed an inspection of Societal CDMO Gainesville, LLC on Jan 24, 2018 in Gainesville, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 24, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gainesville, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |