FDA Inspection 944315 — DSC Laboratories, Inc.
The FDA completed an inspection of DSC Laboratories, Inc. on Aug 25, 2015 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 25, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Muskegon, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |