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Drug Compounder Working Under Unsanitary Conditions, FDA Reports

After a March review, the FDA stated that the Alabama-based Medaus Pharmacy has sterility issues in its facility prompting concerns regarding the safety of its products. The FDA issued a warning letter on January 15, 2014, notifying the drug compounder that state health regulators and inspectors found the pharmacy was selling drugs without prescriptions. Such a violation of the law gives the FDA authority to inspect the compounder.

Upon FDA inspection, the FDA discovered unsanitary conditions at the facility. The FDA also found that employees were not wearing sterile clothing, hairnets, beard covers, or facemasks while filling drug vials with sterile drugs. The ISO 5 area where sterile drugs were processed was also “not suitable for aseptic processing” because the ceiling had unsealed panels and lacked proper filters. Furthermore, the FDA found that the hood designs in the room did not “provide adequate protection” and it noted the problem of low quality air in the room from unidirectional airflow.  The FDA’s letter warned Medaus Pharmacy that these “serious deficiencies in your practices for producing sterile drug products . . . put patients at risk.” Based on the FDA’s inspection, the regulator determined that the Pharmacy was in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).

In September 2013, Medaus Pharmacy recalled 11 drug products, including lipo injections with lidocaine, after the FDA questioned the quality control standards of the lab that the pharmacy was testing for drug sterility. Last year, Congress gave the FDA more regulatory authority over drug compounding companies after a fatal outbreak of meningitis was found to be linked to a contaminated drug made by a compounding pharmacy.

 

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