FDA Inspection 1198226 — SriSai Biopharmaceutical Solutions LLC
The FDA completed an inspection of SriSai Biopharmaceutical Solutions LLC on February 23, 2023 in Frederick, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Frederick, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 17772 | 21 CFR 212.40(b) | Written specifications - components |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |