Pure Source LLC – FDA Inspection, Sep 29, 2009

Record Details

This FDA Inspection record concerns Pure Source LLC, with an inspection on September 29, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Pure Source LLC
Inspection Date: September 29, 2009
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 2ac09523-2600-490f-afa0-f431f22ed6b8

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 615235
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.196Distribution Record Requirements
21 CFR 211.192Quality control unit review of records
21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
21 CFR 211.125(f)Procedures Written and Followed
21 CFR 211.142Written warehousing procedures established/followed
21 CFR 211.180(e)Records reviewed annually
21 CFR 211.170(b)Annual visual exams of drug products
21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
21 CFR 211.22(c)Approve or reject procedures or specs

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Other FDA inspections of Pure Source LLC

Date	Classification	Office	Project area
July 28, 2026	NAI	Florida District Office	Postmarket Assurance: Devices
October 21, 2025	Not classified	Florida District Office	Drug Quality Assurance
August 31, 2023	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 14, 2019	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
March 1, 2018	OAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices