FDA Inspection 942919 — Bright Innovation Labs
The FDA completed an inspection of Bright Innovation Labs on Sep 16, 2015 in Santa Clarita, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 16, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Clarita, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |