Denver Solutions, LLC, dba Leiters Health
FDA 503B outsourcing facility
Buena, New Jersey
Key Takeaways
- FDA-registered 503B outsourcing facility since 2022
- Sterile compounding from bulk substances: Yes
- Not yet inspected by the FDA
- 22 FDA drug recalls on record (2021 to 2025)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- July 1, 2022
- Most recent registration
- November 26, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- Not yet inspected
Denver Solutions, LLC, dba Leiters Health has registered with the FDA as a 503B outsourcing facility but has not yet been inspected. The FDA inspects registered facilities on a risk-based schedule once drug production and distribution are confirmed.
FDA recall history
Denver Solutions, LLC, dba Leiters Health has 22 FDA drug recalls on record between 2021 and 2025, based on the FDA enforcement database. Breakdown: 6 Class I, 13 Class II, 3 Class III.
Recall reasons on record include lack of assurance of sterility: leaking/damaged syringes; presence of particulate matter: glass vials from the manufacturer showed signs of glass; superpotent drug: semi-automated iv bag filling system can malfunction and provide a; labeling: not elsewhere classified; cgmp deviations.
| Date | Class | Product | Reason |
|---|---|---|---|
| March 2025 | Class II | Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. | Lack of Assurance of Sterility: Leaking/damaged syringes. |
| March 2025 | Class II | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Hea | Lack of Assurance of Sterility: Leaking/damaged syringes. |
| March 2025 | Class II | Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71 | Lack of Assurance of Sterility: Leaking/damaged syringes. |
| March 2025 | Class II | Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71 | Lack of Assurance of Sterility: Leaking/damaged syringes. |
| March 2025 | Class II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blv | Lack of Assurance of Sterility: Leaking/damaged syringes. |
Showing the 5 most recent of 22 recall events.
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
Compounded peptides and GLP-1s
Denver Solutions, LLC, dba Leiters Health has not assigned NDCs or filed product reports in the most recent FDA reporting periods. 503B outsourcing facilities are a primary supply route for compounded peptides and GLP-1s during FDA-listed shortages; PeptideGrids grades the evidence for each, including Semaglutide, Tirzepatide, BPC-157, Retatrutide. Browse the GLP-1 and therapeutic peptide databases.
Location
13796 Compark Blvd, N/A, Englewood, CO 80112-7145
Satellite and street imagery via Esri. Open larger map.
Contact
FDA-registered contact: Barbara Knightly Ext 4004, 720-697-5140. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Denver Solutions, LLC, dba Leiters Health with the New Jersey Board of Pharmacy.
503B facilities in New Jersey
Denver Solutions, LLC, dba Leiters Health also operates a registered 503B facility at Englewood, CO.
New Jersey has 10 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in New Jersey.
Frequently asked questions
Is Denver Solutions, LLC, dba Leiters Health registered with the FDA?
Yes. Denver Solutions, LLC, dba Leiters Health is a registered 503B outsourcing facility, first registered with the FDA on July 1, 2022 and most recently registered on November 26, 2025.
Has Denver Solutions, LLC, dba Leiters Health been inspected by the FDA?
Denver Solutions, LLC, dba Leiters Health has registered with the FDA but has not yet been inspected as a 503B outsourcing facility.
Has Denver Solutions, LLC, dba Leiters Health had any FDA drug recalls?
Denver Solutions, LLC, dba Leiters Health has 22 FDA drug recalls on record (2021 to 2025) in the FDA enforcement database.
What does Denver Solutions, LLC, dba Leiters Health compound?
Denver Solutions, LLC, dba Leiters Health has not filed product reports with NDC-assigned drugs in the most recent FDA reporting periods.
Where is Denver Solutions, LLC, dba Leiters Health located?
Denver Solutions, LLC, dba Leiters Health is located in Buena, New Jersey (13796 Compark Blvd).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Denver Solutions, LLC, dba Leiters Health. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.