FDA Inspection 656931 — SOCIETAL CDMO SAN DIEGO, LLC
The FDA completed an inspection of SOCIETAL CDMO SAN DIEGO, LLC on April 1, 2010 in San Diego, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 1, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 10022 | 21 CFR 310.305(a) | Failure to develop written procedures |
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |