FDA Inspection 1169632 — NYSARC, Columbia County Chapter, Inc.
The FDA completed an inspection of NYSARC, Columbia County Chapter, Inc. on May 13, 2022 in Mellenville, NY. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 13, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mellenville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |