FDA Cites Sterile Manufacturing Failures at Texas Drug Maker

FDA has issued a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation, citing widespread GMP violations at the company’s Houston facility, including serious deficiencies in sterile drug production, process controls, and laboratory testing. The 2/5 Warning Letter follows an FDA inspection conducted 8/25–29/2025 at the contract manufacturer over-the-counter drug product manufacturing facility.

During the inspection, FDA says it cited major failures related to sterile manufacturing, stating that Bio-Medical lacked adequate written procedures to prevent microbiological contamination and had not validated aseptic or sterilization processes. Investigators found that the facility did not maintain classified cleanrooms or ISO 5 conditions for aseptic operations and produced drug products labeled as sterile without aseptic processing or terminal sterilization.

The agency also documented insanitary conditions, including filling operations conducted on porous concrete floors, stagnant water in hoses used for formulation, and inadequate environmental controls. The agency said these conditions posed “an unacceptable risk to patients,” including the potential for infection. FDA also noted that company representatives demonstrated an insufficient understanding of GMP requirements for sterile drug manufacturing.

The letter also outlined deficiencies in equipment design and process validation. FDA found that the company used poorly designed water systems that could promote microbial growth and failed to conduct process validation, cleaning validation, and equipment qualification for both sterile and non-sterile products.

Additionally, FDA cited inadequate laboratory controls, including failures to conduct sterility testing for products required to be sterile and insufficient microbiological testing for non-sterile products. According to the agency, Bio-Medical released drug products without adequate scientific evidence demonstrating identity, strength, quality, and purity.

FDA instructed the firm to conduct retrospective testing of retained samples for distributed products and to take corrective actions, including customer notification or recalls if quality defects are identified. The agency also advised Bio-Medical to retain a qualified CGMP consultant to perform a comprehensive audit and oversee remediation efforts.