FDA Inspection 792738 — Blaine Labs Inc
The FDA completed an inspection of Blaine Labs Inc on July 23, 2012 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). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 23, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Fe Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2035 | 21 CFR 211.194(e) | Stability testing records not included |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |