In a letter sent last month the US regulator said Ko Da had acknowledged the violations obsevred by its inspector in a response letter sent in May 2015.
However, the agency also pointed out that the firm has not committed to implement “any corrective actions.”
The FDA said: “Until you completely correct all violations and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer.
Ko Da’s facility in Taoyuan City manufacturers “Chinese Herbal Extracts, Health Food, Natural Cosmetics.”
However, the FDA’s concerns are about its failure to adhere to CFR 211. Specifically, that “Ko Da’s quality control unit failed to approve or reject all procedures or specifications impacting the identity, strength, quality, and purity of the drug product.”
The Agency also said Ko Da had “failed to establish adequate written procedures for production and process controls, including validation protocols and reports, designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.”
The FDA advised Ko Da to hire a compliance consultant to help bring the facility up to code.
Ko Da did not respond to a request for comment.