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1208022

Parker Laboratories, Inc. — FEI 2212018

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 14, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fairfield, NJ (United States)

Facility

Other inspections at this facility

  • 1207536 (VAI Tue May 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046670 (VAI Tue Mar 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900194 (VAI Wed Oct 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 725184 (NAI Thu May 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 567373 (VAI Thu Feb 19 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
191421 CFR 211.166(a)Lack of written stability program
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
437321 CFR 211.188(b)(7)Actual yield, % of theoretical yield
439121 CFR 211.180(e)(2)Items to cover on annual reviews