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844933

Syntho Pharmaceuticals, Inc. — FEI 3003407422

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 23, 2013
Fiscal Year
2013
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))
  • 984108 (OAI Fri Aug 26 2016 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
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
144821 CFR 211.111Establishment of time limitations
194321 CFR 211.180(e)(1)Review of representative number of batches
362921 CFR 211.170(b)Reserve samples identified, representative, stored
363021 CFR 211.170(b)Drug product reserve containers