# FDA 483 - MANDELAY KFT - October 17, 2019

Source: https://www.keypedia.com/records/483/mandelay-kft/19941150-3a85-4604-86c9-10141ab2c4a8

> FDA 483 for MANDELAY KFT on October 17, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MANDELAY KFT
- Inspection Date: 2019-10-17
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MANEKLAY KFT, a medical device manufacturer in Tokol, Hungary, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate design control for their Quest9 device, insufficient complaint handling procedures, and a lack of established environmental control procedures for electrostatic discharge. Additionally, the firm failed to maintain complete Device History Records for device labeling.

## Related Documents

- [WARNING_LETTER - 2019-10-17](https://www.keypedia.com/records/warning_letter/mandelay-kft/22c2bd07-9dea-444f-8e93-edc1a38fe9b5)

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/mandelay-kft/7f43d01a-bfdb-449d-b4f9-51a87cca1158

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