FDA Inspection 791736 — Clinical Encapsulation Service

Clinical Encapsulation Service — FEI 3000215310

The FDA completed an inspection of Clinical Encapsulation Service on July 26, 2012 in Schenectady, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 26, 2012
Fiscal Year
2012
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Schenectady, NY (United States)

Citations

IDCFRDescription
1554621 CFR 111.260(f)Batch record - yield
1573221 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
1573621 CFR 111.353Manufacturing operations - written procedures
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier