FDA Inspection 856746 — Fruit Of The Earth, Inc.

Fruit Of The Earth, Inc. — FEI 1420298

The FDA completed an inspection of Fruit Of The Earth, Inc. on Jan 30, 2014 in Grand Prairie, TX. 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). 11 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 30, 2014
Fiscal Year
2014
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Grand Prairie, TX (United States)

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
145421 CFR 211.115(a)Reprocessing procedures not written or followed
179821 CFR 211.82(b)Quarantine Storage of Components
180221 CFR 211.84(b)Representative Samples
191421 CFR 211.166(a)Lack of written stability program
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
241921 CFR 211.198(a)Complaint Handling Procedure
357021 CFR 211.100(a)Approval and review of procedures
357321 CFR 211.101(b)Measured components for manufacturing

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.