FDA Inspection 1013956 — HR Pharmaceuticals, Inc
The FDA completed an inspection of HR Pharmaceuticals, Inc on Jun 13, 2017 in York, PA. 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
- Jun 13, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- York, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |