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1177872

Birchwood Laboratories, LLC — FEI 2182825

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 19, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Eden Prairie, MN (United States)

Facility

Other inspections at this facility

  • 1271905 (NAI Tue Jun 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1205565 (NAI Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022736 (VAI Fri Aug 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 950518 (NAI Mon Oct 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812984 (VAI Mon Jan 07 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation