503B Docket

GenoGenix LLC 503B outsourcing facility · Raton, FL

This is a record of what FDA published, not a rating. Last FDA inspection and Form 483 status below are as published in FDA's registered outsourcing facilities table (as of Sep 30, 2026).

FDA registration record

Listed by FDA asGenoGenix LLC, Raton, FL
City / stateRaton, FL
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)1-561-264-7303
Initial registration date2/4/2025
Most recent registration date2/11/2026
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)7/18/2025
Form 483 issued at last inspection?Yes
Recall conducted? (FDA table)N/A
Action based on last inspectionOpen
“Open” means FDA has not determined whether further action will be taken (per FDA's table notes).
Intends to compound sterile drugs from bulk substancesYes
Self-reported by the facility at registration; FDA notes this information has not been verified by FDA.

Source: FDA Registered Outsourcing Facilities

Published FDA records

1Form 483 records
0Warning letters
0Recall events (openFDA)
2Uncertain-match items

Counts include only items from FDA's table or exact name + city + state matches. They are counts of published records, not a score. Uncertain matches are shown below but not counted.

State board of pharmacy license lookup

Florida Department of Health License Verification (Board of Pharmacy) (license lookup)

Search the state board's lookup for this facility's license status and any disciplinary actions. We link to the state-level tool only and do not list license numbers. FDA's table does not include state board actions. Facilities that ship across state lines may also hold non-resident licenses in your state, so check your own state's board too.

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Timeline of FDA actions

Newest first. Sources: FDA's registration table, FDA's compounding actions page (2019 onward on the live page), and openFDA drug enforcement records. Items marked Uncertain match may relate to a different site or entity and are not counted. How matching works.

  1. Warning letter Uncertain match
    Warning Letter (01/20/2026)
    Listed on FDA page under: GenoGenix, LLC, Boca Raton, FL - 503B Facility
    Why uncertain: Name and state match; city listed as 'Boca Raton' vs 'Raton' in FDA's registration table
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  2. Recall Uncertain match
    Recall event 97369
    Class I, Class II · Ongoing · 57 product line(s) · Recall no. D-0038-2026, D-0039-2026, D-0040-2026, D-0041-2026, D-0042-2026, D-0043-2026 …
    Recalling firm as listed: GenoGenix LLC, Boca Raton, FL. Reason: Lack of Assurance of Sterility; Microbial Contamination of Sterile Products: elevated endotoxin levels
    Why uncertain: Name and state match; city listed as 'Boca Raton' vs 'Raton' in FDA's registration table
    openFDA record · openFDA drug enforcement API
  3. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: Yes
    No document link published · FDA registered outsourcing facilities table
  4. Form FDA 483 FDA table
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("Amended 483 Issued 07/18/2025 (PDF - 4.7MB)"). That listing is an uncertain match: Name and state match; city listed as 'Boca Raton' vs 'Raton' in FDA's registration table
    FDA document · FDA registered outsourcing facilities table

Possibly related FDA listings (uncertain)