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947089

Amryt Pharmaceuticals, Inc. — FEI 3009569098

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 16, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Boston, MA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1180597 (NAI Wed Sep 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122448 (NAI Thu Jan 23 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 797858 (NAI Mon Aug 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
241921 CFR 211.198(a)Complaint Handling Procedure
261821 CFR 211.198(b)(1)Complaint Record required information
673521 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events