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# Pure Source Inspection Finds CGMP Violations
- URL: https://www.fdaweb.com/pure-source-inspection-finds-cgmp-violations/
- Published: 2019-02-26T12:00:00.000Z
- Updated: 2026-09-15T01:08:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143465

A 2/8-3/1/18 FDA inspection at the Pure Source drug manufacturing facility in Doral, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/20 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631837.htm?ref=fdaweb.com) says specific violations were: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
- failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods; and
- failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all written production and process control procedures.

The letter says that two unidentified drug products are misbranded homeopathic drugs that also are not listed with FDA. It notes that homeopathic drugs are subject to the same regulatory requirements as other drugs and says that homeopathic products offered for conditions not amenable to over-the-counter use must be marketed as prescription products.

The firm acts as a contract manufacturer for drug products, the agency says. It says the firm’s failure to comply with CGMP may significant affect the quality, safety, and efficacy of the drugs it produces.

The letter recommends that Pure Source retain a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance and assist it in meeting CGMP requirements.

Pure Source was told to correct the cited violations promptly and to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence with a timetable for completion of the steps.