FDA Inspection 1084312 — ARCH-Quakertown
The FDA completed an inspection of ARCH-Quakertown on March 28, 2019 in Quakertown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Quakertown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |