# FDA 483 - Engler Engineering Corp. - November 08, 2022

Source: https://www.keypedia.com/records/483/engler-engineering-corp/13b4c904-8cd0-4bf4-ab6a-3e4c6a1e0c45

> FDA 483 for Engler Engineering Corp. on November 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Engler Engineering Corp.
- Inspection Date: 2022-11-08
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Engler Engineering Corp. in Hialeah, FL, was inspected from November 2-8, 2022, and received a Form FDA 483 with three observations. The inspection revealed deficiencies in document control, specifically regarding unsigned/undated handwritten edits and inconsistent procedure numbering. Additionally, the firm failed to include or reference Unique Device Identifiers (UDI) in device history records and lacked proper documentation for personnel training.

## Related Officers

- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.keypedia.com/companies/engler-engineering-corp/5362c608-770a-473d-b9f4-be56ef7c9f9f

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6