FDA Inspection 1004956 — Madison One Acme Inc

Madison One Acme Inc — FEI 2082369

The FDA completed an inspection of Madison One Acme Inc on March 21, 2017 in Los Angeles, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 21, 2017
Fiscal Year
2017
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Los Angeles, CA (United States)

Citations

IDCFRDescription
1575521 CFR 111.205(c)Master manufacturing record: readily available
1582921 CFR 111.70(b)(1)Specifications - component identity
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1584021 CFR 111.70(e)Specifications - contamination limits
1586221 CFR 111.75(a)(2)Appropriate tests, examinations; certificate of analysis
1587121 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
1597621 CFR 111.123Quality control operations - master, batch, manufacturing