Mercator Medsystems, Inc

FDA inspection history in San Leandro, California, 2026

1
Form 483

Every document, by year

  • Form 483

2026: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2026One Form 483, at San Leandro, California.

Cited most

Across all Mercator Medsystems observations on file

  • ISO 13485:2016 Clause 8.2.2
    1

The complete Mercator Medsystems file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2026-03-11483 Form 483$99

Investigators on these documents

Kevin T. Le (1)

FEI number 3004142795 · most recent document Mar 11, 2026

About Mercator Medsystems, Inc

How many FDA Form 483s has Mercator Medsystems, Inc received?

FDA Intel has 1 Form 483 on file for Mercator Medsystems, Inc; the most recent is dated Mar 11, 2026.

When was Mercator Medsystems, Inc last inspected by FDA?

The most recent FDA inspection document on file for Mercator Medsystems, Inc is a Form 483 dated Mar 11, 2026, for the site in San Leandro, California.

What did FDA cite at Mercator Medsystems, Inc?

The regulations cited most in the observations on file for Mercator Medsystems, Inc are ISO 13485:2016 Clause 8.2.2, 1 time.