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# CGMP Violations at Taiwan’s Ko Da Pharmaceutical Company
- URL: https://www.fdaweb.com/cgmp-violations-at-taiwans-ko-da-pharmaceutical-company/
- Published: 2016-06-07T12:00:00.000Z
- Updated: 2026-09-14T21:08:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135858

A 5/25-27/15 FDA inspection at Ko Da Pharmaceutical Co., Taoyuan City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/27 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm504571.htm?ref=fdaweb.com). Specific violations noted include: 

- failure of the firm’s quality unit to approve or reject all procedures or specifications affecting the identity, strength, quality, and purity of a drug product;
- failing to establish adequate written procedures for production and process controls, including validation protocols and reports, designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
- failing 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; and
- failing to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch.

The letter acknowledges the firm’s admission of significant violations of CGMP regulations and decision to stop marketing and distributing its unnamed drug product in the U.S. The firm did not commit to any corrective actions for the CGMP violations. The letter says that if the firm decides to resume manufacturing for the U.S. market, the agency strongly recommends that it engage a qualified consultant to assist it in meeting CGMP requirements.