FDA 483 - Algunas Inc., dba Woodland Hills Compounding Pharmacy - October 11, 2018

This FDA Form 483 was issued to Algunas Inc., dba Woodland Hills Compounding Pharmacy, located at 20631 Ventura Blvd Ste 305, Woodland Hills, CA 91364-2352. The inspection, conducted from October 4-11, 2018, identified the firm as a producer of non-sterile drugs. Steven A. Levin, Pharmacist-In-Charge / Owner / CEO, was the recipient of the report.

The sole observation noted was the use of a non-pharmaceutical grade component in drug product formulations. Specifically, since 2017, the firm used a non-USP grade water system, which was not routinely tested for production quality and contamination risks. This non-pharmaceutical grade water was used in the preparation of numerous non-sterile drug products, including:

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