503B Docket

Qualgen LLC 503B outsourcing facility · Edmond, OK

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 asQualgen LLC, Edmond, OK
City / stateEdmond, OK
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)405-463-4141
Initial registration date5/23/2015
Most recent registration date12/17/2025
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)9/4/2025
Form 483 issued at last inspection?Yes
Recall conducted? (FDA table)No
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.
Prior compounding inspection history flagYes
FDA footnotes this facility as the subject of at least one previous compounding inspection that resulted in a Form 483, warning letter or other action.

Source: FDA Registered Outsourcing Facilities

Published FDA records

4Form 483 records
0Warning letters
5Recall events (openFDA)
0Uncertain-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

Oklahoma State Board of Pharmacy (board site)

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.

Verify directly

Represent this facility? Claim this profile. Claimed profiles never change FDA records.

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. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: Yes
    No document link published · FDA registered outsourcing facilities table
  2. Form FDA 483 FDA table
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 09/04/2025 (PDF - 1.78MB)")
    FDA document · FDA registered outsourcing facilities table
  3. Recall Matched
    Recall event 97086
    Class III · Ongoing · 1 product line(s) · Recall no. D-0517-2025
    Recalling firm as listed: Qualgen, LLC, Edmond, OK. Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
    openFDA record · openFDA drug enforcement API
  4. Form FDA 483 Matched
    483 Issued 03/19/2024 (PDF - 3MB)
    Listed on FDA page under: Qualgen LLC, Edmond, OK - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  5. Court / enforcement action Matched
    FDA Press Release: Federal Court Enters Consent Decree Against Oklahoma Drug Compounder (12/19/2022)
    Listed on FDA page under: Qualgen LLC, Edmond, OK - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  6. Form FDA 483 Matched
    483 Issued 09/30/2022 (PDF - 1.69MB)
    Listed on FDA page under: Qualgen LLC, Edmond, OK - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  7. Form FDA 483 Matched
    483 Issued 06/15/2021 (PDF - 2.5MB)
    Listed on FDA page under: Qualgen LLC, Edmond, OK - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  8. Recall Matched
    Recall event 81346
    Class II · Terminated · 14 product line(s) · Recall no. D-0225-2019, D-0226-2019, D-0227-2019, D-0228-2019, D-0229-2019, D-0230-2019 …
    Recalling firm as listed: Qualgen, LLC, Edmond, OK. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  9. Recall Matched
    Recall event 80203
    Class III · Terminated · 2 product line(s) · Recall no. D-0892-2018, D-0893-2018
    Recalling firm as listed: Qualgen, LLC, Edmond, OK. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date.
    openFDA record · openFDA drug enforcement API
  10. Recall Matched
    Recall event 77064
    Class II · Terminated · 8 product line(s) · Recall no. D-0889-2017, D-0890-2017, D-0891-2017, D-0892-2017, D-0893-2017, D-0894-2017 …
    Recalling firm as listed: Qualgen, Edmond, OK. Reason: CGMP deviations- Lack of Quality Assurance
    openFDA record · openFDA drug enforcement API
  11. Recall Matched
    Recall event 72401
    Class II · Terminated · 2 product line(s) · Recall no. D-0386-2016, D-0387-2016
    Recalling firm as listed: Qualgen, Edmond, OK. Reason: Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
    openFDA record · openFDA drug enforcement API