FDA 483 - Linde Gas & Equipment Inc - October 19, 2023

Linde Gas & Equipment Inc, a manufacturer in Livingston, TN, was cited by the FDA for significant deficiencies in its quality system. The inspection revealed inadequate procedures and implementation for corrective and preventive actions, including failure to investigate recurring quality problems and document changes. Additionally, the firm lacked established procedures for the rework of nonconforming products.