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819296

Amphastar Pharmaceuticals, Inc. — FEI 3002936358

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 6, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rancho Cucamonga, CA (United States)

Facility

Other inspections at this facility

  • 1266798 (NAI Thu Apr 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229403 (VAI Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1144508 (NAI Tue Jun 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113865 (NAI Fri Nov 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115634 (NAI Thu Nov 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
360321 CFR 211.160(b)Scientifically sound laboratory controls
437321 CFR 211.188(b)(7)Actual yield, % of theoretical yield