EarthLab Holdings Inc – FDA Inspection, Jun 21, 2013

Record Details

This FDA Inspection record concerns EarthLab Holdings Inc, with an inspection on June 21, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: EarthLab Holdings Inc
Inspection Date: June 21, 2013
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · da017509-6385-40b2-bf37-6b3714882779

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 816466
FDA center: Human Drugs
Project area: Unapproved and Misbranded Drugs

FDA Citations

21 CFR 211.165(d)Acceptance criteria for sampling & testing
21 CFR 211.122(d)Label storage access limited to authorized personnel
21 CFR 211.150(b)Recall facilitation
21 CFR 211.101(b)Measured components for manufacturing
21 CFR 211.192Quality control unit review of records
21 CFR 211.165(f)Failing drug products not rejected
21 CFR 211.63Equipment Design, Size and Location
21 CFR 211.84(e)Rejecting When Specifications Not Met
21 CFR 211.110(b)In-process materials specifications
21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications

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Other FDA inspections of EarthLab Holdings Inc

Date	Classification	Office	Project area
April 8, 2024	VAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
April 24, 2023	VAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
April 14, 2022	OAI	Center for Food Safety and Applied Nutrition	Colors and Cosmetics Technology
August 26, 2019	NAI	Center for Food Safety and Applied Nutrition	Foodborne Biological Hazards
September 30, 2016	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance