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752766

Crown Laboratories — FEI 1019820

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 3, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Johnson City, TN (United States)

Facility

Other inspections at this facility

  • 1254956 (VAI Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050586 (NAI Thu Mar 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045454 (NAI Thu Feb 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 973822 (VAI Fri Apr 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898298 (OAI Wed Sep 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

  • Injunction (47) (Tue Jul 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113621 CFR 211.25(c)Inadequate number of personnel
116421 CFR 211.28(c)Unauthorized Personnel in Limited Access Areas
194321 CFR 211.180(e)(1)Review of representative number of batches
358521 CFR 211.110(a)Control procedures to monitor and validate performance
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440621 CFR 211.194(a)(2)Suitability of testing methods verified
979221 CFR 106.30(b)(3)Stability analysis