1129358
Wayne County Chapter of NYARC — FEI 3004290217
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Newark, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |