832048
BLI International, Inc. — FEI 3001195380
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Deer Park, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |