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1291300

BioMed Laboratories, LLC. — FEI 3006784948

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 31, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dallas, TX (United States)

Facility

Other inspections at this facility

  • 1296004 (VAI Fri Dec 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155482 (NAI Wed Oct 13 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068501 (VAI Thu Oct 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1069006 (NAI Fri Jul 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028289 (NAI Fri Sep 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
358121 CFR 211.101(d)Verification of component addition
360321 CFR 211.160(b)Scientifically sound laboratory controls