FDA Inspection 789900 — J R Carlson Laboratories Inc.

J R Carlson Laboratories Inc. — FEI 1417272

The FDA completed an inspection of J R Carlson Laboratories Inc. on April 12, 2012 in Arlington Heights, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 12, 2012
Fiscal Year
2012
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Arlington Heights, IL (United States)

Citations

IDCFRDescription
1538221 CFR 111.8Written procedures - personnel qualifications
1540221 CFR 111.12Personnel - quality control personnel - qualified
1577621 CFR 111.415(d)Packaging, labeling - physical separation
1580021 CFR 111.560(a)(2)Product complaint - quality control investigate
1580921 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
1592721 CFR 111.103Written procedures - quality control operations
1604721 CFR 111.510Returned dietary supplement - material review, disposition
1605221 CFR 111.530Returned dietary supplement - investigation