FDA WARNING_LETTER - Wells Pharma of Houston LLC - March 28, 2025

The FDA issued a Warning Letter to Wells Pharma of Houston, LLC on November 7, 2025, following an inspection from March 17 to March 28, 2025. The letter identifies serious deficiencies, placing patients at risk, and states that drug products produced by the company failed to meet the conditions for outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).Key violations include the failure to properly label compounded drugs with the required "This is a compounded drug" statement and inadequate procedures for submitting adverse event reports, specifically lacking a complete definition of "serious" adverse events. Consequently, the company"s drug products are not eligible for exemptions from FDA approval requirements, adequate directions for use labeling, and Drug Supply Chain Security Act provisions.Furthermore, the FDA found drug products to be adulterated due to insanitary conditions and numerous Current Good Manufacturing Practice (CGMP) violations. Insanitary conditions observed included operators blocking critical airflow, media fills not performed under challenging conditions, inadequate smoke studies, and cracked/discolored plexiglass in sterile areas. CGMP violations encompassed a failure to establish procedures preventing microbiological contamination, inadequate environmental monitoring, insufficient investigation of discrepancies, deficient quality control, and poor labeling control. The company must implement comprehensive corrective actions to address these serious issues and comply with regulatory standards.