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823829

Milbar Laboratories, Inc. — FEI 2435254

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 2, 2013
Fiscal Year
2013
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))
  • 971848 (VAI Tue May 17 2016 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
149521 CFR 211.122(a)Written procedures describing in detail
200821 CFR 211.186(a)Written procedures followed
241921 CFR 211.198(a)Complaint Handling Procedure
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
440221 CFR 211.192Written record of investigation incomplete