# FDA 483 - Bionet Co., Ltd. - February 18, 2019

Source: https://www.globalkeysolutions.net/records/483/bionet-co-ltd/84b143c8-851b-4883-a94a-8e2bf4ca60bb

> FDA 483 for Bionet Co., Ltd. on February 18, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bionet Co., Ltd.
- Inspection Date: 2019-02-18
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection from February 18-21, 2019, Pionet Co. Ltd. was cited for inadequate establishment and implementation of corrective and preventive action (CAPA) procedures. Specifically, the firm's CAPA procedure was not adequately implemented, as nonconformities were not consistently reviewed as inputs into the system. This indicates a significant lapse in a fundamental quality system process.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/bionet-co-ltd/cc3fa3ab-ef3f-470c-9265-6522e8aefaee

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