FDA 483 - Linde Gas & Equipment Inc. - July 25, 2025

An FDA Form 483 was issued to KVK-Tech, Inc. following an inspection conducted from November 20 to December 15, 2023, at its Newtown, PA drug manufacturing facility. The inspection identified several critical deficiencies in the company's adherence to Current Good Manufacturing Practices (CGMP), many of which were repeat observations from prior inspections in 2019, 2021, and 2022.

Key violations included inadequate written procedures for quality system annual reviews and the scope of complaint and out-of-specification (OOS) investigations. The firm repeatedly failed to thoroughly investigate OOS results for various drug products, often closing investigations without a definitive root cause or appropriate corrective actions. Procedures designed to prevent microbiological contamination during sterile processing were found deficient, with operators observed violating aseptic techniques. The Quality Assurance department approved batch records containing missing information, incorrect calculations, and uninvestigated discrepancies, indicating a lack of proper oversight. Production procedures were not consistently followed or documented in real-time. Additionally, the firm had not adequately established and documented the accuracy of test methods, failed to perform routine equipment calibration, and did not ensure employees received adequate and current CGMP training. KVK-Tech, Inc. is required to address these systemic issues to ensure full compliance with federal regulations.