# FDA 483 - Kyowa Hakko Bio Co., Ltd. - November 08, 2019

Source: https://www.keypedia.com/records/483/kyowa-hakko-bio-co-ltd/2b59b559-fc24-4243-abb8-b6ee8265f928

> FDA 483 for Kyowa Hakko Bio Co., Ltd. on November 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kyowa Hakko Bio Co., Ltd.
- Inspection Date: 2019-11-08
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of KYOWA HAKKO BIO CO., LTD. in Hofu-shi, Japan, an API manufacturer, revealed a significant failure to thoroughly review unexplained discrepancies. Specifically, the firm did not always perform adequate investigations into out-of-specification (OOS) results for microbial limits, lacking documented justifications for re-sampling and re-testing or failing to evaluate all potential root causes including cleaning validation.

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## Related Officers

- [Sneha Patel](https://www.keypedia.com/people/sneha-patel/b7425bea-67ce-4c9b-af5a-51515bdd9f2e)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/kyowa-hakko-bio-co-ltd/4ab0756a-78b6-4060-8087-809db6e7941b

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd