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984108

Syntho Pharmaceuticals, Inc. — FEI 3003407422

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 26, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Farmingdale, NY (United States)

Facility

Other inspections at this facility

  • 1101047 (OAI Tue Sep 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003899 (OAI Thu Mar 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844933 (OAI Fri Aug 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 768857 (OAI Tue Feb 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754919 (OAI Mon Nov 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
144821 CFR 211.111Establishment of time limitations
145421 CFR 211.115(a)Reprocessing procedures not written or followed
176721 CFR 211.137(a)Expiration date lacking
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
180921 CFR 211.160(a)Following/documenting laboratory controls
181021 CFR 211.160(a)Lab controls established, including changes
189121 CFR 211.165(f)Failing drug products not rejected
192621 CFR 211.166(b)Adequate number of batches on stability
197721 CFR 211.182Dedicated equipment: records part of batch record
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
359121 CFR 211.110(b)In-process materials specifications
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures
361521 CFR 211.160(b)(4)Test devices not meeting specifications
430321 CFR 211.67(b)Written procedures fail to include
430621 CFR 211.80(a)Written Procedures Not Followed
439121 CFR 211.180(e)(2)Items to cover on annual reviews