Japanese Firm Slammed for Falsifying Certificates of Analysis

Japanese drugmaker Daito Kasei Kogyo was hit with a warning letter by the FDA for having inadequate testing procedures and falsifying certificates of analysis issued to customers from its facility in Bizen, Okayama.

During a July inspection, the agency noted the company released numerous drugs without conducting all the required testing. The facility failed to run tests for quality and identity and could not show drug products conformed to specifications.

In addition, the agency found the facility’s quality control unit signed COAs and issued them to customers, indicating all required testing had been completed on relevant drug batches. However, the agency discovered the company had falsified the certificates. For example, the COA reported results of impurity and identity tests that were never conducted at the facility.