483
Sumitomo Chemical Co., Ltd.FDA 483 - Sumitomo Chemical Co., Ltd.
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Record Details
An FDA inspection of Sumitomo Chemical Company, Limited, an API manufacturer in Ampachi-Gun, Japan, revealed two significant objectionable conditions. The firm's sampling procedures for raw materials were found to be non-representative, and inadequate controls were in place to prevent excessive access privileges to laboratory control records, raising concerns about data integrity.
- Company
- Sumitomo Chemical Co., Ltd.
- Product Type
- Drugs
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ID · a472768a-0694-48ca-9d2d-564aeeef4a53