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1175552

KVK Tech, Inc. — FEI 3005117563

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 8, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Newtown, PA (United States)

Facility

Other inspections at this facility

  • 1233334 (OAI Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229759 (NAI Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086467 (OAI Tue Apr 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066940 (NAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016049 (VAI Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
202221 CFR 211.188(b)(10)Documentation of Sampling Performed
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
356521 CFR 211.58Buildings not maintained in good state of repair
359421 CFR 211.110(d)Rejected in-process materials not quarantined
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs