Home / Facilities / 3013417188

SOFREGEN MEDICAL INC. — FDA Facility Profile

FEI 3013417188

SOFREGEN MEDICAL INC. is an FDA-registered facility (FEI 3013417188) located in Framingham, MA, US. RegDataLab tracks 1 FDA inspection at this facility.

Reviewing SOFREGEN MEDICAL INC. 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 SOFREGEN MEDICAL INC. 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
Jul 31, 2019: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
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
Jul 31, 2019Voluntary Action Indicated (VAI)DMR - not or inadequately maintained (21 CFR 820.181)

Facility details

Company
Sofregen Medical Inc.
Location
Framingham, MA (US)
Source
device

FDA data resources

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