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1290200

WES Pharma Inc. — FEI 3010062344

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 20, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Westminster, MD (United States)

Facility

Other inspections at this facility

  • 1223324 (VAI Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1162565 (NAI Fri Feb 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1141774 (NAI Wed Apr 28 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114327 (VAI Fri Dec 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088267 (NAI Fri Apr 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

  • Injunction (103) (Thu Apr 09 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
441321 CFR 211.194(a)(8)Second person sign off