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971848

Milbar Laboratories, Inc. — FEI 2435254

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 17, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
East Haven, CT (United States)

Facility

Other inspections at this facility

  • 1231023 (NAI Tue Jan 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180954 (OAI Tue Sep 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107471 (OAI Fri Oct 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036724 (OAI Wed Dec 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 823829 (VAI Tue Apr 02 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
200821 CFR 211.186(a)Written procedures followed
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
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)