FDA Inspection 1013218 — Prepared Meals Co

Prepared Meals Co — FEI 2520768

The FDA completed an inspection of Prepared Meals Co on April 24, 2017 in Moosic, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 24, 2017
Fiscal Year
2017
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Moosic, PA (United States)

Citations

IDCFRDescription
1813821 CFR 117.10Personnel
1814021 CFR 117.20(b)Plant construction and design
1814221 CFR 117.35(a)Sanitary operations - Plant sanitation
1814421 CFR 117.35(b)(2)Toxic chemicals - Identified, held, stored
1814921 CFR 117.40Equipment and utensils - Design and maintenance
1816121 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls
1816321 CFR 117.80(c)(8)Process control - Foreign objects
1816521 CFR 117.93Storage and Distribution
601021 CFR 123.8(a)(3)(i)Monitoring record review adequacy
90121 CFR 123.6(a)Hazard analysis
91821 CFR 123.8(a)Verification - reviewers qualifications
95921 CFR 123.6(c)(1)Food safety hazards
96121 CFR 123.6(c)(3)Critical limits