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631294

VMM Enterprises, Inc. — FEI 3003393295

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 10, 2009
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Safety Harbor, FL (United States)

Facility

Other inspections at this facility

  • 1050819 (NAI Fri Apr 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027024 (VAI Fri Sep 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798046 (VAI Mon Sep 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
184221 CFR 211.84(d)(1)Component identity verification
197521 CFR 211.182Written records kept in individual logs
200721 CFR 211.186(a)Signature and checking of records -- 2 persons
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
439121 CFR 211.180(e)(2)Items to cover on annual reviews