Ecotec Manufacturing, Inc
Form 483 issued February 5, 2026 · Okeechobee, Florida
- Inspection
- Feb 2 – Feb 5, 2026
- Investigator
- Alex J. Wild
- Observations
- 3
- Pages
- 4
- FEI number
- 3004825240
In short: On February 5, 2026, FDA issued a Form 483 with 3 observations to Ecotec Manufacturing, Inc in Okeechobee, Florida (FEI 3004825240) after an inspection that ran Feb 2 – Feb 5, 2026. The investigator was Alex J. Wild.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 8.5.2
Corrective action procedures defining the requirements for determining the causes of nonconformities have…
- 02ISO 13485:2016 Clause 8.2.2
Complaint handling records were…
- 03ISO 13485:2016 Clause 8.3.4
Records of rework were…
This inspection in context
Alex J. Wild
4 documents · 2023–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmEcotec Manufacturing, Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Ecotec Manufacturing, Inc?
FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Ecotec Manufacturing, Inc?
Alex J. Wild is named on this Form 483, for the inspection of Feb 2 – Feb 5, 2026. Each investigator has a profile showing what they cite most.
When was Ecotec Manufacturing, Inc inspected by FDA?
The inspection ran Feb 2 – Feb 5, 2026, and the Form 483 is dated February 5, 2026.
How do I get the full Form 483 for Ecotec Manufacturing, 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.