879264
BLI International, Inc. — FEI 3001195380
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 7, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Deer Park, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3555 | 21 CFR 211.48(b) | Drains--Size, Back-siphonage Prevention |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |
| 3631 | 21 CFR 211.170(b) | Investigation of reserve sample deterioration |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |