FDANews
The QMN Weekly Bulletin

FDA Finds Quality Void at California Compounder

June 2, 2017

In a March 2017 visit to a compounding facility in Chatsworth, Calif., the FDA found there was no one in charge of quality.

TSDR Pharmacy did not have a quality control unit and none of the drug preparation activities were reviewed or verified by a second person, according to the Form 483.

Master formulation and batch compounding records lacked essential details, including mixing information and in-process testing documentation. Other quality lapses discovered included a lack of API identification testing when ingredients were received.

The facility also lacked documented testing quality procedures or quantitative analysis of the finished products supporting product label claims, and proper tests or documentation for microorganisms or the efficacy of the preservatives.

In addition, there were no written procedures for cleaning or sanitization of the equipment used to prepare the products, inspectors found. The company did not respond to a request for comment.

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