FDA 483 - TOYO Pharmaceutical Co., Ltd. - June 12, 2026
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TOYO Pharmaceutical Co., Ltd., a drug manufacturer in Osaka, Japan, was cited with four observations during an FDA inspection. The findings primarily concern deficiencies in quality control documentation practices, inadequate computer system controls for production equipment, and improper storage and annual examination of drug product reserve samples. These issues indicate a need for improved adherence to GMP regulations regarding record-keeping, data integrity, and sample management.
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