Engler Engineering Corp.
Form 483 issued November 8, 2022 · Hialeah, Florida
- Inspection
- Nov 2 – Nov 8, 2022
- Investigator
- Ebony D. Sanon
- Observations
- 3
- Pages
- 4
- FEI number
- 1036336
In short: On November 8, 2022, FDA issued a Form 483 with 3 observations to Engler Engineering Corp. in Hialeah, Florida (FEI 1036336) after an inspection that ran Nov 2 – Nov 8, 2022. The investigator was Ebony D. Sanon. Most observations concern records & documents and management controls.
At a glance
2 of 3 observations on this 483 concern records & documents.
What FDA observed
Preview: the opening words of each observation- 01
Document control procedures have…
- 02
The device histoiy record does not include, or refer to the location of any unique device…
- 03
Personnel training is not…
This inspection in context
Ebony D. Sanon
8 documents · 2022–2026
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Florida.
The firmEngler Engineering Corp. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.40
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Engler Engineering Corp.?
FDA listed 3 observations on this Form 483, mostly about records & documents and management controls. The opening words of each observation are shown on this page.
Who inspected Engler Engineering Corp.?
Ebony D. Sanon is named on this Form 483, for the inspection of Nov 2 – Nov 8, 2022. Each investigator has a profile showing what they cite most.
When was Engler Engineering Corp. inspected by FDA?
The inspection ran Nov 2 – Nov 8, 2022, and the Form 483 is dated November 8, 2022.
How do I get the full Form 483 for Engler Engineering Corp.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.