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1165323

Lynx Medical Pennsylvania — FEI 2528981

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 25, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Erie, PA (United States)

Facility

Other inspections at this facility

  • 1062318 (VAI Fri Aug 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923685 (NAI Fri Apr 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 848369 (NAI Thu Sep 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712892 (NAI Mon Mar 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
136121 CFR 211.100(a)Absence of Written Procedures
440221 CFR 211.192Written record of investigation incomplete