FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Inspections and Audits

Ko Da Receives Warning Letter Over GMP Violations

June 14, 2016
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The FDA is calling out a Taiwanese drugmaker for a slew of GMP violations circling its quality control unit's written procedures, rendering its products adulterated.

A May inspection conducted at Ko Da Pharmaceutical’s Taoyuan City facility revealed that the firm fell short in approving or rejecting all procedures or conditions affecting drug quality, the May 27 letter states. For example, the firm released drug products without being inspected as appropriate.

The agency also took aim at the firm’s lack of written procedures for validation protocols and reports to ensure drug quality, and procedures designed to assure batch uniformity and integrity of drug products.

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