FDA Inspection 1050162 — Q A Laboratories Inc
The FDA completed an inspection of Q A Laboratories Inc on April 19, 2018 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 19, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 16494 | FDCA 601(c) | Insanitary conditions; contaminated with filth |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 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 |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |