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609003

Ferndale Laboratories, Inc. — FEI 1811212

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 26, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Ferndale, MI (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1163686 (VAI Fri Mar 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1024384 (NAI Wed Aug 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005288 (VAI Fri Feb 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924621 (VAI Fri Apr 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 858400 (VAI Tue Jan 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
241921 CFR 211.198(a)Complaint Handling Procedure
261821 CFR 211.198(b)(1)Complaint Record required information
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
673021 CFR 314.80(b)Failure to develop written procedures
682921 CFR 314.80(c)(2)Failure to report non-alert ADEs