FDA Inspection 824908 — Medical Horizons Inc

Medical Horizons Inc — FEI 2000001261

The FDA completed an inspection of Medical Horizons Inc on Apr 18, 2013 in North Salt Lake, UT. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Apr 18, 2013
Fiscal Year
2013
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
North Salt Lake, UT (United States)

Citations

IDCFRDescription
1549221 CFR 111.25(a)Procedures - calibrating instruments
1550821 CFR 111.27(a)(5)(ii)Refrigerator, freezer - alarm
1553221 CFR 111.255(b)Batch record - complete
1576321 CFR 111.205(a)Master manufacturing record - unique formulation
1579621 CFR 111.430(b)Records - packaging, labeling operations
1585321 CFR 111.73Specifications met - identity, purity, strength, composition
1592721 CFR 111.103Written procedures - quality control operations