Home / Inspections / 760599

760599

Renu Laboratories, Inc. — FEI 3003263206

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 28, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Warminster, PA (United States)

Facility

Other inspections at this facility

  • 1254082 (NAI Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175495 (VAI Wed Jul 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026865 (VAI Tue Sep 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
180121 CFR 211.84(a)Components withheld from use pending release
181021 CFR 211.160(a)Lab controls established, including changes
191221 CFR 211.166(a)Written program not followed
197521 CFR 211.182Written records kept in individual logs
200921 CFR 211.188Prepared for each batch, include complete information
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure