Mercator Medsystems, Inc
Form 483 issued March 11, 2026 · San Leandro, California
- Inspection
- Mar 9 – Mar 11, 2026
- Investigator
- Kevin T. Le
- Observations
- 1
- Pages
- 4
- FEI number
- 3004142795
In short: On March 11, 2026, FDA issued a Form 483 with 1 observation to Mercator Medsystems, Inc in San Leandro, California (FEI 3004142795) after an inspection that ran Mar 9 – Mar 11, 2026. The investigator was Kevin T. Le. The most-cited regulation is 21 CFR 8.2.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 8.2.2
Justification for not investigating a complaint(s) was not documented. Procedures for complaint handling have…
This inspection in context
Kevin T. Le
3 documents · 2026
Cites 820.10 (requirements for a quality management system) more than any other section. Most of their documents are for sites in Washington.
The firmMercator Medsystems, Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Mercator Medsystems, Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 8.2. The opening words of each observation are shown on this page.
Who inspected Mercator Medsystems, Inc?
Kevin T. Le is named on this Form 483, for the inspection of Mar 9 – Mar 11, 2026. Each investigator has a profile showing what they cite most.
When was Mercator Medsystems, Inc inspected by FDA?
The inspection ran Mar 9 – Mar 11, 2026, and the Form 483 is dated March 11, 2026.
How do I get the full Form 483 for Mercator Medsystems, 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.