FDA Inspection 762707 — Himalayan Int'l Inst. of Yoga Science and Phil. of the USA

Himalayan Int'l Inst. of Yoga Science and Phil. of the USA — FEI 3004609853

The FDA completed an inspection of Himalayan Int'l Inst. of Yoga Science and Phil. of the USA on January 18, 2012 in Honesdale, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 18, 2012
Fiscal Year
2012
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Honesdale, PA (United States)

Citations

IDCFRDescription
1549421 CFR 111.25(c)Procedures - equipment - cleaning, sanitizing
1552621 CFR 111.30(c)Equipment - automated - calibrate, inspect
1557821 CFR 111.155(c)Components - quarantine
1570821 CFR 111.325(a)Written procedures, laboratory operations
1576321 CFR 111.205(a)Master manufacturing record - unique formulation
1580921 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1601421 CFR 111.140(b)(1)QC ops; written procedures; material review, disposition
1605721 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures