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850250

Avista Pharma Solutions, Inc. — FEI 1220785

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 27, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Agawam, MA (United States)

Facility

Other inspections at this facility

  • 1278383 (VAI Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113974 (VAI Wed Dec 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067530 (NAI Wed Sep 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988732 (VAI Wed Jun 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 696758 (NAI Wed Oct 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
142121 CFR 211.42(c)(10)Aseptic Processing Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
181021 CFR 211.160(a)Lab controls established, including changes
188321 CFR 211.165(a)Testing and release for distribution
202721 CFR 211.192Investigations of discrepancies, failures
431421 CFR 211.84(d)(2)Reports of Analysis (Components)