FDA Issues Warning Letter to Taiwan Facility

June 8, 2016

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

FDA issued a warning letter on May 27, 2016 to KO DA Pharmaceutical Co. (Taoyuan City, Taiwan) for violations of current good manufacturing practice (cGMP). The warning letter follows an FDA inspection of the company’s facility in May 2015.

During the May 2015 inspection, FDA inspectors observed that the company’s quality control unit had “failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 Code of Federal Regulations (CFR) 211.22(c)).” The company also had not established written procedures for production and process controls or for the preparation of master production and control records. FDA states in the warning letter that the company also “failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)).”  

The company’s response to the FDA inspection was to stop manufacture and distribution of product to the US market; however, the company did not provide FDA with corrective actions to address the cGMP violations. FDA recommends the company acquire a consultant to assist the company in fixing the cGMP violations. FDA requests the company provide the agency with a corrective and preventive action plan to address the violations.

Source: FDA