Florida Company Receives FDA Warning Letter

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FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.

FDA sent a warning letter, dated Dec. 3, 2020, to over-the-counter drug manufacturer Clientele after an inspection of the company’s Sunrise, FL facility found violations of current good manufacturing practices (CGMPs). The company was cited for misbranded drugs and a variety of quality control issues.

Specifically, investigators found the company did not have an adequate quality unit and failed to ensure that microbiological testing was performed, suppliers were adequately qualified, or out-of-specification results were thoroughly investigated. The company also failed to ensure that an ongoing stability program was established and annual product reviews were performed. The agency is requesting the company perform an assessment of its quality unit and provide a remediation plan.

In addition, the company also failed to establish adequate laboratory controls and written production and process procedures. It also did not “establish and follow an adequate written testing program designed to assess the stability characteristics of drug product and to use results of stability testing to determine appropriate storage conditions and expiration dates,” according to the warning letter.


Source: FDA