FDA 483 - Delpharm Dijon - May 31, 2024

An FDA inspection of Delpharm Dijon, a sterile drug manufacturer located in Quetigny, France, was conducted from May 23 to May 31, 2024. This inspection resulted in the issuance of a Form FDA 483, identifying two significant observations related to the company's adherence to Good Manufacturing Practices. The first observation noted deficiencies in the master production and control records. Specifically, these records failed to include statements of theoretical yield, along with minimum, maximum, and actual yield percentages for intermediate bulk drug manufacturing, which are essential for monitoring consistency in product quality and quantity. The second observation highlighted the absence of established time limits for critical production phases. The firm had not performed adequate hold-time studies to determine chemical and microbiological hold times for several process steps. Furthermore, their commercial production batch records did not clearly identify specific steps requiring such hold-time controls for intermediate bulk drugs. Delpharm Dijon is now required to implement comprehensive corrective actions to address these observations and ensure full compliance with regulatory standards for drug product quality and manufacturing process controls.