American Pure Whey – FDA Inspection, Jul 12, 2019

Record Details

This FDA Inspection record concerns American Pure Whey, with an inspection on July 12, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company: American Pure Whey
Inspection Date: July 12, 2019
Product Type: Food/cosmetics
Office: Center for Food Safety and Applied Nutrition
Person: Lourene S. Phillips (Issuing Officer)

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ID · b74665c3-7be0-46f0-8e5b-602fbd92b68b

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1096962
FDA center: Foods & Cosmetics
Project area: Food Composition, Standards, Labeling and Econ
Outcome: Form 483 issued

FDA Citations

21 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
21 CFR 111.70(a)Specifications - manufacturing process
21 CFR 111.15(b)(1)Physical plant - clean and sanitary
21 CFR 111.180(b)(2)Records - receiving; components, packaging, labels, products
21 CFR 111.475(b)(2)Records - product distribution
21 CFR 111.180(b)(1)Written procedures - product received
21 CFR 111.255(a)Batch record - every batch
21 CFR 111.15(d)(2)Pest control measures
21 CFR 111.20(f)Physical plant - bulbs, fixtures, skylights

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Other FDA inspections of American Pure Whey

Date	Classification	Office	Project area
November 17, 2016	OAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
September 18, 2015	OAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ