Home / Inspections / 858400

858400

Ferndale Laboratories, Inc. — FEI 1811212

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 14, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ferndale, MI (United States)

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))
  • 756786 (VAI Tue Dec 13 2011 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
180221 CFR 211.84(b)Representative Samples
185221 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
360321 CFR 211.160(b)Scientifically sound laboratory controls