The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.
On June 2, 2016, FDA sent a
During the FDA inspection, inspectors found that the company “failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.” The company also failed to assure that their products “have the identity, strength, quality, and purity they purport or are represented to possess” by not having written procedures for production and process controls.
FDA also stated that the company did not have appropriate stability testing and “failed to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit”
In the letter, FDA stated, “If your firm resumes manufacturing drugs for the United States market, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Using a consultant does not relieve your firm’s obligation to comply with CGMP. Notify this office, in writing, of the specific steps that you have taken to correct violations and prevent recurrence. Provide supporting documentation. If your firm cannot complete corrective actions, state the reasons and the date by which your firm will have completed the corrections.”
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