Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.March 22, 2024

FDA 483 - Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. - March 22, 2024

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Record Details

The FDA inspected Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. in Tokushima, Japan, a manufacturer of drug products and sterile/non-sterile drug substances. The inspection revealed significant deficiencies in equipment cleaning, environmental monitoring for aseptic processing, adherence to sampling plans, raw material testing, and investigation of product discrepancies. These findings indicate a need for improved quality control and manufacturing practices to ensure drug product safety and quality.

Company: Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Inspection Date: March 22, 2024
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Patty P. Kaewussdangkul (Investigator)

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ID · ae73bd67-e93b-48af-8279-d731014ad321