Wutek Orthopaedics, Inc
Form 483 issued November 19, 2024 · Fort Lauderdale, Florida
- Inspection
- Nov 15 – Nov 19, 2024
- Investigator
- Ebony D. Sanon
- Observations
- 9
- Pages
- 8
- FEI number
- 3005893246
In short: On November 19, 2024, FDA issued a Form 483 with 9 observations to Wutek Orthopaedics, Inc in Fort Lauderdale, Florida (FEI 3005893246) after an inspection that ran Nov 15 – Nov 19, 2024. The investigator was Ebony D. Sanon. Most observations concern management controls and production & process controls.
At a glance
Observations span 4 systems, led by management controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchaseid or otherwise received product and se rvices conform to specified…
- 02
Docmnent control procedures have not been…
- 03
A device history record has…
- 04
Procedures for finished device acceptance have not been…
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 firmWutek Orthopaedics, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wutek Orthopaedics, Inc?
FDA listed 9 observations on this Form 483, mostly about management controls, production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Wutek Orthopaedics, Inc?
Ebony D. Sanon is named on this Form 483, for the inspection of Nov 15 – Nov 19, 2024. Each investigator has a profile showing what they cite most.
When was Wutek Orthopaedics, Inc inspected by FDA?
The inspection ran Nov 15 – Nov 19, 2024, and the Form 483 is dated November 19, 2024.
How do I get the full Form 483 for Wutek Orthopaedics, Inc?
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.