# FDA 483 - Asanuma Corporation - June 15, 2018

Source: https://www.keypedia.com/records/483/asanuma-corporation/5d85de11-e69c-4de3-b99b-2a05bd0c6779

> FDA 483 for Asanuma Corporation on June 15, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asanuma Corporation
- Inspection Date: 2018-06-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Asanuma Corporation, an OTC drug manufacturer in Sagamihara-shi, Japan, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate controls over computerized systems, deficient testing and sampling procedures, and a lack of proper written procedures and adherence to change control for manufacturing, packaging, and quality control processes. The firm also failed to adequately qualify equipment and document complaint investigations.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.keypedia.com/companies/asanuma-corporation/e104d3e4-f1e1-4f7e-be80-da497c424685

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