FDA Inspection 676243 — Blaine Labs Inc
The FDA completed an inspection of Blaine Labs Inc on August 12, 2010 in Santa Fe Springs, CA. 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
- August 12, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Fe Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |