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1278174

BLA Enterprises, LLC dba Green Mountain Pharmaceuticals — FEI 3008763196

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 6, 2025
Fiscal Year
2025
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Lakewood, CO (United States)

Facility

Other inspections at this facility

  • 1158653 (VAI Mon Dec 13 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108047 (VAI Tue Sep 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 995721 (VAI Thu Dec 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1544421 CFR 111.15(c)(1)Cleaning compounds
1553321 CFR 111.255(c)Batch record - follow master
1575921 CFR 111.205(b)(2)Master manufacturing record - controls, procedures
1588621 CFR 111.77(b)Specifications not met - identity; component, reject
2284321 CFR 111.70(b)Specifications - components
2288521 CFR 111.205(a)Master manufacturing record - followed
2288821 CFR 111.210Master manufacturing record - record requirements