FDA Inspection 682156 — SriSai Biopharmaceutical Solutions LLC
The FDA completed an inspection of SriSai Biopharmaceutical Solutions LLC on September 24, 2010 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
- September 24, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Frederick, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |