# FDA 483 - B. Braun Aesculap Japan Co., Ltd. - April 10, 2014

Source: https://www.globalkeysolutions.net/records/483/b-braun-aesculap-japan-co-ltd/b4fd1cf1-e05b-4e1f-9f2d-89988f5e8741

> FDA 483 for B. Braun Aesculap Japan Co., Ltd. on April 10, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B. Braun Aesculap Japan Co., Ltd.
- Inspection Date: 2014-04-10
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of B. BRAUN AESCULAP JAPAN CO., LTD. in Tochigi-Shi, Japan, from April 7-10, 2014, revealed a significant lapse in quality control. The firm failed to document equipment calibrations for a critical environmental monitoring device used in the manufacturing of epidural anesthesia needles, with the device reportedly not calibrated since January 2009. This indicates a potential risk to product quality and patient safety due to uncontrolled manufacturing conditions.

## Related Officers

- [Matthew J. Morrison](https://www.globalkeysolutions.net/people/matthew-j-morrison/fe149072-c4b0-45a9-ab96-b6184b1caaf7)

Company: https://www.globalkeysolutions.net/companies/b-braun-aesculap-japan-co-ltd/2b68ba53-9b6c-4755-8514-c876a2b766f7

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