FDA Inspection 731711 — DSC Laboratories, Inc.
The FDA completed an inspection of DSC Laboratories, Inc. on June 27, 2011 in Muskegon, MI. 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
- June 27, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Muskegon, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |