FDA 483 - Linde, Inc. - March 11, 2026

The FDA conducted an inspection of the Linde Industrial Gas facility located in La Porte, Indiana, from March 9 to March 11, 2026. This regulatory assessment, documented on Form 483, identified significant concerns regarding the integrity of equipment used in the processing of medical gases. The primary violation involved the use of cracked and fractured gaskets within the filling hoses that connect to trailer truck shipping containers. These damaged components pose a risk of particulate contamination, as equipment surfaces in direct contact with medical gases must be maintained to ensure they do not alter the safety, purity, or quality of the product. Investigators noted that the company failed to provide validation studies or evidence that their current filtration systems are capable of removing microscopic gasket debris from the finished drug product. This inspection was performed under the authority of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While these observations do not represent a final determination of non-compliance by the agency, the facility is required to address the issues. Linde Industrial Gas must provide a written response to the FDA"s Detroit District Office detailing their corrective actions or any objections to the findings to ensure the ongoing safety of their medical gas operations.