# FDA 483 - Nihon Kohden America LLC - April 30, 2019

Source: https://www.keypedia.com/records/483/nihon-kohden-america-llc/3b2c1099-94c8-4bdb-8edb-734c424e3f37

> FDA 483 for Nihon Kohden America LLC on April 30, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nihon Kohden America LLC
- Inspection Date: 2019-04-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Nihon Kohden America Inc., a medical device importer and manufacturer in Irvine, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to submit timely and complete Medical Device Reports (MDRs), inadequately documented corrective and preventive actions (CAPAs), and did not properly investigate customer complaints. Additionally, training procedures were found to be insufficient, and a critical quality agreement with a product manufacturer had expired.

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.keypedia.com/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)
- [Sonya L. Karsik](https://www.keypedia.com/people/sonya-l-karsik/c24603b9-5ca0-46f5-861a-b367155b0def)

Company: https://www.keypedia.com/companies/nihon-kohden-america-llc/6d634199-3448-4668-ae42-2ca3ea095b6a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6