FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - June 07, 2023

The FDA conducted an inspection of FUJIFILM Diosynth Biotechnologies Texas, LLC, a biological drug substance manufacturer located in College Station, Texas, from May 31 to June 7, 2023. The inspection revealed several significant compliance issues primarily related to the quality control unit and the validation of analytical methods.

Key observations include the failure of the quality control unit to adequately monitor and evaluate critical quality control tests, particularly concerning system suitability failures in binding immunoassays. There was a noted delay in initiating investigations into recurring assay failures, with one type contributing to 62% of invalid assay rates. Additionally, the firm was found to be using analytical test methods that had not been appropriately validated, compromising the assurance of product purity, potency, identity, and quality.

Furthermore, the company did not adhere to its Supplier Monitoring Program, failing to initiate supplier complaints for defective materials and closing investigations without resolution. The inspection also highlighted inadequate control procedures for validating manufacturing processes, specifically the lack of bioburden and endotoxin data to support process validation for certain batches.

The FDA requires FUJIFILM Diosynth Biotechnologies to address these deficiencies by implementing corrective actions to ensure compliance with regulatory standards, including revising quality control procedures, validating all analytical methods before use, and strengthening supplier monitoring protocols. The firm is expected to communicate any objections or corrective actions to the FDA promptly.