Home / Facilities / 3009596585

CALIMEX USA CORPORATION — FDA Facility Profile

FEI 3009596585

CALIMEX USA CORPORATION is an FDA-registered facility (FEI 3009596585) located in Gilroy, CA, US. RegDataLab tracks 2 FDA inspections at this facility.

Reviewing CALIMEX USA CORPORATION as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check CALIMEX USA CORPORATION yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

What FDA found at this site

Latest inspection
Feb 24, 2014: No Action Indicated (NAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 24, 2014No Action Indicated (NAI)No citations listed
May 22, 2013Voluntary Action Indicated (VAI)Procedures not adequately established or maintained (21 CFR 820.40)
Design plans - Lack of or inadequate (21 CFR 820.30(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Management review - Lack of or inadequate procedures (21 CFR 820.20(c))
and 1 more

Facility details

Company
Calimex USA Corporation
Location
Gilroy, CA (US)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.