FDA Inspection 657113 — Glanbia Performance Nutrition

Glanbia Performance Nutrition — FEI 3002591065

The FDA completed an inspection of Glanbia Performance Nutrition on Apr 15, 2010 in Aurora, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Apr 15, 2010
Fiscal Year
2010
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Aurora, IL (United States)

Citations

IDCFRDescription
1575921 CFR 111.205(b)(2)Master manufacturing record - controls, procedures
1593421 CFR 111.105(c)Quality control - basis; in-process, component, specifications
1596621 CFR 111.117(a)Quality control operations - calibrating processes
1605121 CFR 111.525(b)Returned dietary supplement - release
1606621 CFR 111.35(b)(1)(i)Written procedures - instruments, controls; calibrating

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.