Conroe Welding Supply, Inc – FDA Warning Letter, Apr 3, 2026

Conroe Welding Supply, Inc., located in Conroe, Texas, received an FDA warning letter following an inspection conducted from March 30 to April 3, 2026. The agency identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for medical gases under the Federal Food, Drug, and Cosmetic Act. The findings indicate that the firm’s medical gas products, including Oxygen USP, are considered adulterated due to inadequate manufacturing and quality controls.

The primary violations include a failure to perform essential identity and strength testing on finished medical gas batches before distribution. Notably, an investigator discovered that a technician falsified testing records for oxygen tanks that were later found to contain 99% of an incorrect gas, representing a life-threatening risk to patients. The firm also failed to test incoming raw materials, neglected to validate supplier certificates of analysis, and provided insufficient oversight through its Quality Unit. Furthermore, the company failed to adequately investigate serious complaints, such as water contamination in high-pressure cylinders and gas mix-ups reported by hospitals.

To address these deficiencies, the FDA requires Conroe Welding Supply to hire an independent consultant to perform a comprehensive audit and assist in remediating their quality system. The company must conduct a thorough retrospective review of data integrity, implement a robust corrective and preventive action (CAPA) plan, and provide evidence of improved laboratory and documentation practices. Finally, the firm must clarify whether it intends to continue manufacturing medical gases for the U.S. market and demonstrate full compliance before future distribution can proceed.