# FDA 483 - J.:)o,,a Hakko Bio Co., Ltd. - April 15, 2022

Source: https://www.keypedia.com/records/483/joa-hakko-bio-co-ltd/827866f8-6e7d-44d8-9154-9bb9a5a06ba8

> FDA 483 for J.:)o,,a Hakko Bio Co., Ltd. on April 15, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: J.:)o,,a Hakko Bio Co., Ltd.
- Inspection Date: 2022-04-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details multiple observations regarding the facility's quality control, change management, materials, laboratory, and production systems.

**Observation 1** highlights failures within the quality control unit to follow established procedures. This includes:
*   Not establishing root causes or issuing CAPAs for poor endotoxin test calibration curves (LE2022-HB-002, LE2022-HB-004, LE2022-HB-018).
*   Lacking risk assessments for major deviations (DV-21-007:2) and proper investigations for deviations with potential product impact (DV-1596).
*   SOP YIS-QA-0039-02 lacking criteria for extending deviations, leading to several deviations remaining open for extended periods (e.g., DV-21-0591 for 275 days).
*   A backlog of over 300 open change controls, CAPAs, and complaint investigations, with many exceeding 100 days, and insufficient documentation of their progress despite SOP requirements.

**Observation 2** addresses inadequate evaluation of proposed changes:
*   Change Control CC-21-0292 for DIW water system holding tanks did not assess microbial growth risk during system shutdown or justify not increasing monitoring post-service.
*   Change Control CC21-0

## Related Officers

- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.keypedia.com/companies/joa-hakko-bio-co-ltd/b64e0bf3-e4c0-4255-9e85-9803ae2ed37e

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c