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FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
FDA sent a warning letter, dated Jan. 26, 2018, to Celltrion, Inc. after inspectors found current good manufacturing practice (CGMP) violations at the company’s Incheon facility in the Republic of Korea. Problems with the company’s aseptic processes were observed.
During the inspection, which took place from May 22–June 2, 2017, FDA personnel saw poor aseptic practices during the set-up and filling of batches. The agency stated the company did not perform proper retrospective investigations and risk assessments of the product that was affected. In the letter, the agency stated, “your revised procedure FF21024 permits contamination of product-contact surfaces during set-up, followed by wiping with a disinfectant, instead of preventing sterile equipment contamination by improved design and procedures.”
Investigators also found deficiencies in the company’s smoke studies and media fill operations. Training procedures were lacking, according to FDA, and revised media fill procedures did not address product already affected. The agency requested the company perform retrospective assessment of all media fills since January 2014 and an independent review of their media fill program.
Batch failures were also not properly investigated, according to the agency. Multiple complaints were received regarding batches of product. The warning letter stated that the company did not investigate and resolve the complaints for more than two years. The agency requested that the company update their corrective action and preventive action plans to prevent the problem from reoccurring and perform a risk assessment, among other actions.
Further aseptic manufacturing problems found included an inadequate environmental monitoring system in aseptic manufacturing areas. “For example, your SOP FF21017 Environmental monitoring in operation for fill and finish process lacked active air monitoring in ISO 5 areas during operations,” FDA stated. The agency requested the company outline improvements to its environmental monitoring program.