FDA Inspection 1158653 — BLA Enterprises, LLC
The FDA completed an inspection of BLA Enterprises, LLC on December 13, 2021 in Lakewood, CO. 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
- December 13, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lakewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |