# FDA 483 - Astellas Pharma Inc. - March 05, 2019

Source: https://www.keypedia.com/records/483/astellas-pharma-inc/bc58294a-3a70-44de-9115-dcad18a40e5f

> FDA 483 for Astellas Pharma Inc. on March 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Astellas Pharma Inc.
- Inspection Date: 2019-03-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Astellas Pharma Tech Co Ltd in Takaoka City, Japan, was inspected by the FDA from February 25 to March 5, 2019, for its human drug product manufacturing. The inspection revealed significant deficiencies across multiple areas, including inadequate investigations into production deviations, failures in preventing microbiological contamination for sterile products, and issues with equipment maintenance and quality control procedures. These observations indicate a lack of robust controls to assure product quality, sterility, and data integrity.

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## Related Officers

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Company: https://www.keypedia.com/companies/astellas-pharma-inc/ad5c1a7d-23cf-412a-88ce-62ab257c3233

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1