503B Docket

Denver Solutions, LLC, dba Leiters Health 503B outsourcing facility · Englewood, CO

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 asDenver Solutions, LLC, dba Leiters Health, Englewood, CO
City / stateEnglewood, CO
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)720-697-5140 Ext 4004
Initial registration date3/24/2017
Most recent registration date11/28/2025
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)12/11/2025
Form 483 issued at last inspection?Yes · View Form 483 (FDA PDF)
Recall conducted? (FDA table)No
Action based on last inspectionUntitled Letter Issued 6/8/2026 · Untitled Letter Issued 6/8/2026
“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

4Form 483 records
0Warning letters
6Recall 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

Colorado DORA License Lookup (State 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. Untitled letter FDA table
    Untitled Letter Issued 6/8/2026
    FDA document · FDA registered outsourcing facilities table
  2. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: Yes
    FDA document · FDA registered outsourcing facilities table
  3. Form FDA 483 FDA table
    Form FDA 483 (linked from FDA's registration table)
    FDA document · FDA registered outsourcing facilities table
  4. Recall Matched
    Recall event 96607
    Class II · Ongoing · 5 product line(s) · Recall no. D-0370-2025, D-0371-2025, D-0372-2025, D-0373-2025, D-0374-2025
    Recalling firm as listed: Denver Solutions, LLC DBA Leiters Health, Englewood, CO. Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
    openFDA record · openFDA drug enforcement API
  5. FMD-145 letter Matched
    FMD-145 Letter Issued 11/20/2024
    Listed on FDA page under: Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  6. Form FDA 483 Matched
    483 Issued 04/05/2024 (PDF - 2 MB)
    Listed on FDA page under: Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  7. Recall Matched
    Recall event 94071
    Class II · Ongoing · 3 product line(s) · Recall no. D-0361-2024, D-0362-2024, D-0363-2024
    Recalling firm as listed: Denver Solutions, LLC DBA Leiters Health, Englewood, CO. Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
    openFDA record · openFDA drug enforcement API
  8. Recall Matched
    Recall event 93710
    Class I · Ongoing · 6 product line(s) · Recall no. D-0277-2024, D-0278-2024, D-0279-2024, D-0280-2024, D-0281-2024, D-0282-2024
    Recalling firm as listed: Denver Solutions, LLC DBA Leiters Health, Englewood, CO. Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
    openFDA record · openFDA drug enforcement API
  9. Recall Matched
    Recall event 93178
    Class III · Terminated · 3 product line(s) · Recall no. D-0070-2024, D-0071-2024, D-0072-2024
    Recalling firm as listed: Denver Solutions, LLC DBA Leiters Health, Englewood, CO. Reason: Labeling: Not Elsewhere Classified
    openFDA record · openFDA drug enforcement API
  10. Recall Matched
    Recall event 91762
    Class II · Terminated · 4 product line(s) · Recall no. D-0442-2023, D-0443-2023, D-0444-2023, D-0445-2023
    Recalling firm as listed: Denver Solutions, LLC DBA Leiters Health, Englewood, CO. Reason: CGMP DEVIATIONS
    openFDA record · openFDA drug enforcement API
  11. FMD-145 letter Matched
    FMD-145 Letter Issued 03/29/2022
    Listed on FDA page under: Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  12. Recall Matched
    Recall event 89136
    Class II · Terminated · 1 product line(s) · Recall no. D-0288-2022
    Recalling firm as listed: Denver Solutions, LLC DBA Leiters Health, Englewood, CO. Reason: Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
    openFDA record · openFDA drug enforcement API
  13. Form FDA 483 Matched
    483 Issued 10/07/2021 (PDF - 9 MB)
    Listed on FDA page under: Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  14. FMD-145 letter Matched
    FMD-145 Letter 05/26/2021
    Listed on FDA page under: Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  15. Form FDA 483 Matched
    483 Issued 07/18/2019 (PDF - 606 KB)
    Listed on FDA page under: Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions