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Empower Pharmacy, a registered outsourcing facility, produced compounded drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for exemptions from drug approval and labeling requirements. An FDA inspection conducted from February to March 2020 identified violations, though the specific compliance failures are not detailed in the provided excerpt. The company's response to the FDA Form 483 was received on March 27, 2020, but the products were deemed to violate the FDCA.