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973822

Crown Laboratories — FEI 1019820

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 8, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Johnson City, TN (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

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))
  • 898298 (OAI Wed Sep 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866595 (OAI Fri Feb 14 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
121 CFR 11Electronic records
241921 CFR 211.198(a)Complaint Handling Procedure
440921 CFR 211.194(a)(4)Data secured in course of each test
670621 CFR 310.305(c)(1)(i)Late submission
8935FDCA 760(b)(1)Failure of responsible person to report AE (non-RX Drug)