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1171967

Jerome Stevens Pharmaceuticals, Inc. — FEI 2431950

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 15, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bohemia, NY (United States)

Facility

Other inspections at this facility

  • 1247238 (NAI Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086248 (VAI Thu Apr 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009653 (VAI Thu Mar 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935880 (VAI Thu Jul 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856030 (VAI Thu Nov 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
239921 CFR 211.194(a)(2)Laboratory Test Method Verification
359221 CFR 211.110(c)In-process materials characteristics testing
432221 CFR 211.101(d)Component release checked by 2nd person
434221 CFR 211.142(b)Storage under appropriate conditions