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

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.