Home / Inspections / 1036724

1036724

Milbar Laboratories, Inc. — FEI 2435254

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 27, 2017
Fiscal Year
2018
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))
  • 971848 (VAI Tue May 17 2016 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
900121 CFR 211.22(a)Lack of quality control unit