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862225

Medical Products Laboratories, Inc. — FEI 2513595

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 24, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Philadelphia, PA (United States)

Facility

Other inspections at this facility

  • 1209945 (VAI Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120626 (VAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028594 (VAI Thu Oct 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935401 (VAI Tue Jul 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746082 (NAI Wed Jul 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
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
145021 CFR 211.113(a)Procedures for non-sterile drug products
1579921 CFR 111.560(a)(1)Product complaint - quality control review
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
356521 CFR 211.58Buildings not maintained in good state of repair
356921 CFR 211.89Quarantine of Rejected Components et. al.
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include
434221 CFR 211.142(b)Storage under appropriate conditions
53721 CFR 820.70(a)Production processes