Atrium, Inc. – FDA Inspection, Jan 24, 2012

Record Details

This FDA Inspection record concerns Atrium, Inc., with an inspection on January 24, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company: Atrium, Inc.
Inspection Date: January 24, 2012
Product Type: Food/cosmetics
Office: Center for Food Safety and Applied Nutrition

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ID · 6d1ee180-9e13-4441-a7d7-3da0411c294f

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 764698
FDA center: Foods & Cosmetics
Project area: Foodborne Biological Hazards

FDA Citations

21 CFR 111.83(a)Reserve sample - collect, hold
21 CFR 111.70(b)(1)Specifications - component identity
21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
21 CFR 111.70(e)Specifications - identity, purity, strength, composition
21 CFR 111.103Written procedures - quality control operations
21 CFR 111.553Written procedures - product complaint
21 CFR 111.410(c)Packaging, labels - master manufacturing record
21 CFR 111.375(b)Records - manufacturing operations; written procedures
21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
21 CFR 111.205(a)Master manufacturing record - each batch

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Other FDA inspections of Atrium, Inc.

Date	Classification	Office	Project area
July 17, 2014	OAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
May 20, 2013	OAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ