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PQ Pharmacy, LLC, an outsourcing facility registered to compound sterile drugs, produced 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. During an FDA inspection conducted March 25–April 4, 2025, investigators identified serious deficiencies in the facility's practices for producing drugs intended to be sterile, creating patient safety risks and resulting in the production of adulterated drug products that violated federal law. The facility received an FDA Form 483 with noted violations and submitted a response on April 7, 2025, but these corrective actions were insufficient to prevent the issuance of this warning letter.