FDA Inspection 947089 — Amryt Pharmaceuticals, Inc.
The FDA completed an inspection of Amryt Pharmaceuticals, Inc. on Jul 16, 2015 in Boston, MA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 16, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 2618 | 21 CFR 211.198(b)(1) | Complaint Record required information |
| 6735 | 21 CFR 314.80(c)(1)(ii) | Failure to investigate serious, unexpected events |