American Pure Whey – FDA Inspection, Sep 18, 2015

Record Details

This FDA Inspection record concerns American Pure Whey, with an inspection on September 18, 2015, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company: American Pure Whey
Inspection Date: September 18, 2015
Product Type: Food/cosmetics
Office: Center for Food Safety and Applied Nutrition

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ID · 70667409-7d22-4626-bbc2-7c1886fa99a2

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 942052
FDA center: Foods & Cosmetics
Project area: Food Composition, Standards, Labeling and Econ

FDA Citations

21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
21 CFR 111.553Written procedures - product complaint
21 CFR 111.103Written procedures - quality control operations
21 CFR 111.353Manufacturing operations - written procedures
21 CFR 111.535(b)(2)Records - ret"nd dietary supplement: material review, dispos
21 CFR 111.255(a)Batch record - every batch
21 CFR 111.205(a)Master manufacturing record - each batch
21 CFR 111.75(c)Specifications met - verify; finished batch
21 CFR 111.20(h)Physical plant - screening against pests
21 CFR 111.60(a)Production, in- process control system - design, quality

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Other FDA inspections of American Pure Whey

Date	Classification	Office	Project area
July 12, 2019	OAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
November 17, 2016	OAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ