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Wells Pharma of Houston, LLC, a registered outsourcing facility for compounding sterile drugs, produced drug products that failed to meet the conditions required under Section 503B of the Federal Food, Drug, and Cosmetic Act and contained serious deficiencies in manufacturing practices that put patients at risk. During an FDA inspection conducted March 17-28, 2025, investigators documented violations of current good manufacturing practices and failures to comply with outsourcing facility requirements necessary to qualify for exemptions from drug approval and labeling requirements. The company received a Form FDA 483 on March 28, 2025, and submitted a response on May 9, 2025, but the violations were not adequately remedied, resulting in the warning letter issued November 7, 2025.