Home / Facilities / 3009710316

MLM BIOLOGICS — FDA Facility Profile

FEI 3009710316

MLM BIOLOGICS is an FDA-registered facility (FEI 3009710316) located in Alachua, FL, US. RegDataLab tracks 3 FDA inspections at this facility.

Reviewing MLM BIOLOGICS 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 MLM BIOLOGICS 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
Aug 25, 2026: Voluntary Action Indicated (VAI)
Inspections on record
3 (3 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
Aug 25, 2026Voluntary Action Indicated (VAI)Design and development inputs do not include all requirements (ISO 13485:2016 Clause 7.3.3)
Jun 14, 2023Voluntary Action Indicated (VAI)No citations listed
Nov 7, 2018Voluntary Action Indicated (VAI)Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)

Facility details

Company
MLM Biologics, Inc.
Location
Alachua, FL (US)
Source
device

FDA data resources

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