656959
DSC Laboratories, Inc. — FEI 1831691
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 13, 2010
- Fiscal Year
- 2010
- 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |