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1272618

EPM Packaging, Inc. — FEI 1930466

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 13, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lexington, NE (United States)

Facility

Other inspections at this facility

  • 1195194 (VAI Thu Jan 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 974360 (NAI Wed May 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 974362 (NAI Wed May 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710407 (NAI Wed Mar 02 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710408 (NAI Wed Mar 02 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
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
126621 CFR 211.42(d)Penicillin processing area not kept separate
136121 CFR 211.100(a)Absence of Written Procedures
356221 CFR 211.56(c)Written procedures lacking for use of pesticides etc.