FDA Inspection 578121 — Q A Laboratories Inc
The FDA completed an inspection of Q A Laboratories Inc on April 24, 2009 in Kansas City, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 4397 | 21 CFR 211.186(b)(5) | Calculated excess |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |