FDA Inspection 711614 — SOCIETAL CDMO SAN DIEGO, LLC
The FDA completed an inspection of SOCIETAL CDMO SAN DIEGO, LLC on February 17, 2011 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |