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SK pharmteco Completes Regulatory Inspection of La Porte Facility

The general inspection included tours of the warehouse, manufacturing plant, and analytical laboratories.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

SK pharmteco has successfully completed a regulatory inspection of its small molecule North America facility in La Porte, Texas conducted by the U.S. Food and Drug Administration (FDA).

After a thorough review of the facility’s quality systems and manufacturing operations, the FDA completed the inspection without issuing a Form 483. This “No Action Indicated” (NAI) status confirms that the site complies with the highest regulatory standards.

The general inspection included tours of the warehouse, manufacturing plant, and analytical laboratories. Inspectors conducted an in-depth review of the site’s procedural rigor, assessing batch records, Corrective and Preventive Actions (CAPAs), deviation and Out-of-Specification (OOS) investigations, and change controls. The agency also confirmed the integrity of the site’s equipment qualifications, purified water systems, and process and cleaning validations.

“The successful completion of this FDA inspection directly reflects the commitment to excellence and strong quality culture of our La Porte team,” said Kalen Minvielle, Head of Small Molecule, North America. “Maintaining an NAI status is a significant achievement that continues to highlight the strength of our systems and disciplined approach to building quality into every step of the process. It ensures our customers can continue to rely on SK pharmteco for secure, compliant, and uninterrupted manufacturing of life-enhancing medicines.”

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