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642682

Milbar Laboratories, Inc. — FEI 2435254

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 27, 2010
Fiscal Year
2010
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
110521 CFR 211.22(d)Procedures not in writing, fully followed
136121 CFR 211.100(a)Absence of Written Procedures
138821 CFR 211.101(d)Component addition checked by 2nd person
139521 CFR 211.103Actual vs. theoretical yields not determined
155021 CFR 211.125(f)Procedures Written and Followed
194321 CFR 211.180(e)(1)Review of representative number of batches
431421 CFR 211.84(d)(2)Reports of Analysis (Components)