Amryt Pharmaceuticals, Inc. — FDA Facility Profile
Amryt Pharmaceuticals, Inc. is an FDA-inspected facility (FEI 3009569098) located in Boston, MA, US. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Sep 14, 2022: No Action Indicated (NAI)
- Inspections on record
- 4 (1 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 8, 2013
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 14, 2022 | No Action Indicated (NAI) | No citations listed |
| Jan 23, 2020 | No Action Indicated (NAI) | No citations listed |
| Jul 16, 2015 | Voluntary Action Indicated (VAI) | SOPs not followed / documented (21 CFR 211.100(b)) Complaint Handling Procedure (21 CFR 211.198(a)) Complaint Record required information (21 CFR 211.198(b)(1)) Failure to investigate serious, unexpected events (21 CFR 314.80(c)(1)(ii)) |
| Aug 27, 2012 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Amryt Pharmaceuticals, Inc.
- Location
- Boston, MA (US)
- Source
- inspections