The US Food and Drug Administration has posted a Warning Letter to Austin Biotechnology following an inspection of the company’s manufacturing facility in Taipei, Taiwan for violations of good manufacturing practices for finished pharmaceuticals. The inspection occurred from May 28 to May 29, 2015.

Among the violations cited, the FDA noted that the firm 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 agency also cited the firm for failing to establish written procedures for production and process controls, including validation protocols and reports, designed to assure that the firm's drug products have the identity, strength, quality, and purity they purport or are represented to possess.

The FDA also cited the firm for failing to ensure that its drug products bore an expiration date that was supported by appropriate stability testing and for failing to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates. The agency also said that the firm 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 a response of May 29, 2015, the company acknowledged the significance of the cGMP observations and decided to stop the shipping and distribution of these products in the US and did not commit to any corrective actions regarding the cGMP violations observed on the inspection.

Source: US Food and Drug Administration