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1211562

Sciarra Laboratories, Inc. — FEI 1000306996

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 7, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hicksville, NY (United States)

Facility

Other inspections at this facility

  • 1046128 (VAI Thu Mar 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1041616 (NAI Wed Feb 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925624 (NAI Tue May 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867806 (NAI Fri Feb 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802381 (NAI Thu Oct 04 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
180921 CFR 211.160(a)Following/documenting laboratory controls
191221 CFR 211.166(a)Written program not followed
358521 CFR 211.110(a)Control procedures to monitor and validate performance
361321 CFR 211.160(b)(4)Establishment of calibration procedures