FDA Inspection 895773 — Vege Labs LLC
The FDA completed an inspection of Vege Labs LLC on Sep 15, 2014 in Glendale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 15, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glendale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4576 | 21 CFR 211.192 | No written record of investigation |