FDA Finds Quality Void at California Compounder
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.
Disinfectant efficacy must be established before a new disinfectant can be put on the market. Additionally, manufacturers must validate disinfectant regimens for cleanroom and other controlled areas. Many different standards apply, including AOAC Chapter 6 tests, ASTM E 2315, USP General Chapter 1072 and ASTM E 26140. Don’t risk patient safety, lawsuits and liability, warning letters or Forms 483. Learn how to keep cleanrooms really clean with Disinfectant Testing and Validation today!