# FDA 483 - ZOT ENGINEERING LTD - September 07, 2023

Source: https://www.keypedia.com/records/483/zot-engineering-ltd/315d2325-4472-438a-a316-1ca10b1823a1

> FDA 483 for ZOT ENGINEERING LTD on September 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZOT ENGINEERING LTD
- Inspection Date: 2023-09-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: ZOT ENGINEERING LTD, a medical device contract manufacturer in Musselburgh, United Kingdom, received a Form FDA 483 citing significant deficiencies across its quality system. The inspection revealed inadequate complaint handling procedures, including a failure to evaluate complaints for Medical Device Reporting (MDR) and misclassifying customer events. Additionally, the firm failed to adequately validate manufacturing processes and third-party software applications, and its document control procedures were found to be non-compliant.

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/zot-engineering-ltd/186bd5a0-6169-44fd-ade0-c61b55ac36f0

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