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Hybrid Pharma, LLC, a registered outsourcing facility, produced compounded sterile drug products that failed to meet the regulatory conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for drug approval exemptions. During an FDA inspection from July to September 2021, investigators identified serious deficiencies in the facility's sterile drug manufacturing practices that put patients at risk and determined that the drugs produced violated the FDCA. The company's products did not comply with the necessary conditions for outsourcing facilities, including requirements for direct pharmacist supervision and adherence to current good manufacturing practices for sterile compounding.