FDA Warns Taiwanese Drug Manufacturer Over Significant cGMP Violations
Posted 07 June 2016 | By
The US Food and Drug Administration (FDA) on Tuesday released a warning letter for Taiwanese drug and contract manufacturer Ko Da Pharmaceutical over four specific violations.
The letter from FDA’s Center for Drug Evaluation and Research, sent 27 May, revealed the following significant violations of current good manufacturing practice (cGMP):
- 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 (21 CFR 211.22[c]).
- It 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 (21 CFR 211.100[a]).
- The company 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]).
- Ko Da failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186[a]).
“In your response of May 28, 2015, you acknowledged significant violations of CGMP regulations and ‘decided to stop manufacturing and distributing the product named (b)(4) to the United States market.’ You did not commit to any corrective actions regarding the CGMP violations observed on the inspection,” the short letter reads.
According to the company’s website, its Taoyuan City, Taiwan-based manufacturing facility “has been verified by G.M.P. & ISO 9001:2000 certificates,” and has been manufacturing herbal medicines since 1980.