FDA Inspection 1275862 — DSC Laboratories, Inc.
The FDA completed an inspection of DSC Laboratories, Inc. on Jul 16, 2025 in Muskegon, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 16, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Muskegon, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |