Fagron Group API Facility Receives FDA Warning Over Cleaning Issues

The US Food and Drug Administration (FDA) has issued a warning letter to an active product ingredient (API) facility run by the Netherlands-based Fagron Group. A key accusation was that an employee destroyed cleaning logs, an act deemed more egregious due to the company’s previous issues with the agency regarding cleaning. Concerns regarding cleaning and cross-contamination made it to the current complaint as well.

According to the letter, ““During your API repackaging and relabeling operations, including highly potent drugs such as testosterone, estradiol, betamethasone, tamoxifen and opioids, your firm failed to conduct adequate cleaning validation studies to demonstrate that your cleaning procedures for your non-dedicated “cabins” (production rooms) are adequate to prevent potential cross-contamination.”

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(Source: Endpoints News, June 30th, 2022)