FDA Inspection 728240 — BLI International, Inc.
The FDA completed an inspection of BLI International, Inc. on May 13, 2011 in Deer Park, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 13, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Deer Park, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |