FDA Inspection 1129358 — Wayne County Chapter of NYARC
The FDA completed an inspection of Wayne County Chapter of NYARC on September 16, 2020 in Newark, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
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 |