1158653
BLA Enterprises, LLC dba Green Mountain Pharmaceuticals — FEI 3008763196
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 |