FDA Inspection 1114257 — Sagent Pharmaceuticals
The FDA completed an inspection of Sagent Pharmaceuticals on December 18, 2019 in Schaumburg, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Schaumburg, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |