FDA Inspection 1229563 — General Research Laboratories

General Research Laboratories — FEI 2016158

The FDA completed an inspection of General Research Laboratories on May 24, 2024 in Simi Valley, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 24, 2024
Fiscal Year
2024
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Simi Valley, CA (United States)

Citations

IDCFRDescription
1553221 CFR 111.255(b)Batch record - complete
1576221 CFR 111.205(a)Master manufacturing record - each batch
1582921 CFR 111.70(b)(1)Specifications - component identity
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1583121 CFR 111.70(b)(3)Specifications - contamination limits
1583821 CFR 111.70(d)Specifications - labels, packaging
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1593121 CFR 111.105Quality control - packaged, labeled
1593221 CFR 111.105(a)Quality control - processes, specifications, written procedures