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1163686

Ferndale Laboratories, Inc. — FEI 1811212

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 4, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ferndale, MI (United States)

Facility

Other inspections at this facility

  • 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))
  • 756786 (VAI Tue Dec 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
145021 CFR 211.113(a)Procedures for non-sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures