483
Engler Engineering Corp.Engler Engineering Corp. – FDA 483, Nov 8, 2022
Record Details
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.
View Company Profile
ID · 13b4c904-8cd0-4bf4-ab6a-3e4c6a1e0c45
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.