483
S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITEDS & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED – FDA 483, Jul 21, 2023
Record Details
An FDA inspection of S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED in Si Racha, Thailand, a manufacturer, revealed significant deficiencies in laboratory control systems and quality control unit responsibilities. Observations included failures to maintain complete records for laboratory reference standards and test calculations, as well as a lack of proper written procedures and authority for the quality control unit, leading to concerns about data integrity and batch record control.
- Inspection date
- July 21, 2023
- Product type
- drugs
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ID · b18d44b8-6594-4414-bf2b-0df0a500bc6c
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