483
Kyowa Pharma Chemical Co LtdFDA 483 - Kyowa Pharma Chemical Co Ltd
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Record Details
An FDA inspection of KYOWA PHARMA CHEMICAL CO, LTD in Toyama, Japan, revealed significant deficiencies across multiple areas of their quality system. The firm failed to adequately follow quality unit responsibilities, conduct complete cleaning validation studies, maintain accurate records, and ensure proper laboratory controls. These findings indicate a need for comprehensive improvements in the firm's manufacturing and quality assurance practices.
- Company
- Kyowa Pharma Chemical Co Ltd
- Product Type
- Drugs
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ID · 6f8ede71-74a8-41b2-b7af-e289bc91d362