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# CGMP Violations at Taiwan’s Austin Biotechnology
- URL: https://www.fdaweb.com/cgmp-violations-at-taiwans-austin-biotechnology/
- Published: 2016-06-14T12:00:00.000Z
- Updated: 2026-09-14T21:09:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135929

A 5/28-29/15 FDA inspection at Austin Biotechnology, Taipei, Taiwan, found significant violations of current good manufacturing practice for finished pharmaceuticals, according to a 6/2 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm505558.htm?ref=fdaweb.com). Specific violations cited in the letter included: 

- failing 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;
- 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;
- failing to ensure that the firm’s drug products bear an expiration date that is supported by appropriate stability testing;
- failing to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
- failing to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined.

The letter says that the firm’s 5/29/15 response acknowledged the significance of the CGMP observations and said it had decided to stop the shipping and distribution of its products in the U.S. FDA says that if the firm resumes manufacturing drugs for the U.S. market, it strongly recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements. And, if it decides to resume manufacturing drugs for the U.S., it also should respond with specific steps it has taken to correct the violations, with documentation of each step, and a timetable for completion.