FDA Inspection 664677 — BLI International, Inc.
The FDA completed an inspection of BLI International, Inc. on May 25, 2010 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 25, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Deer Park, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |