Denver Solutions, LLC, dba Leiters Health, Buena

FDA 503B registration status

FDA 503B list ✓ (current 2026-08-10)

Denver Solutions, LLC, dba Leiters Health, Buena appears on FDA's registered outsourcing facilities list, parsed from Veritura's capture of that list (FDA list current as of 2026-08-10, captured 2026-08-16). Registration status can change between captures; the FDA page is the authoritative current source.

On our captures

On FDA's list since we began tracking captures on 2026-07-11 (tracking began 2026-07-10; we make no claim about FDA's list before our first capture). Last confirmed on our 2026-08-11 capture (FDA list current as of 2026-08-10).

Dates are Veritura's own capture dates of FDA's public list, shown next to FDA's list-current date wherever we have it. Public-record posture, not a determination.

FDA enforcement timeline

22 dated enforcement records matched this firm name in openFDA when this check last completed (10 most recent shown).

• 2025-03-31 · drug · Class II · Ongoing
  Lack of Assurance of Sterility: Leaking/damaged syringes.
• 2025-03-31 · drug · Class II · Ongoing
  Lack of Assurance of Sterility: Leaking/damaged syringes.
• 2025-03-31 · drug · Class II · Ongoing
  Lack of Assurance of Sterility: Leaking/damaged syringes.
• 2025-03-31 · drug · Class II · Ongoing
  Lack of Assurance of Sterility: Leaking/damaged syringes.
• 2025-03-31 · drug · Class II · Ongoing
  Lack of Assurance of Sterility: Leaking/damaged syringes.
• 2024-02-20 · drug · Class II · Ongoing
  Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
• 2024-02-20 · drug · Class II · Ongoing
  Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
• 2024-02-20 · drug · Class II · Ongoing
  Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
• 2023-12-28 · drug · Class I · Ongoing
  Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
• 2023-12-28 · drug · Class I · Ongoing
  Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Source: openFDA enforcement records (drug/device/food, updated weekly), checked 2026-08-19. Dated public records matching this firm name; similar firm names collide in public records, so confirm the firm identity against the source records before relying. Public-record posture, not a determination.

Live FDA enforcement screen

22 enforcement record matches on this firm name in openFDA when this screen last ran. Review the underlying public records and confirm the firm identity before relying on this signal.

0 FDA compliance action records matched this name.

Source: openFDA enforcement records and FDA compliance dashboards, refreshed at most every 6 hours. A count here documents what public sources returned for this name (searched: Denver Solutions, LLC, dba Leiters Health, Buena); it is not a Veritura determination about the facility.

Reported products

22 distinct products as reported to FDA in 503B product reports (data vintage: reporting periods 2026-1, 2025-2); 20 shown.

• Bevacizumab · 25 mg/1 mL · injection, solution · reported period 2026-1
• Cyclopentolate Hydrochloride; Tropicamide; Phenylephrine Hydrochloride · 10 mg/1 mL; 10 mg/1 mL; 25 mg/1 mL · solution/ drops · reported period 2026-1
• Dexmedetomidine Hydrochloride · 4 ug/1 mL · injection, solution · reported period 2026-1
• Epinephrine; Bupivacaine Hydrochloride; Dexamethasone Sodium Phosphate · 5 ug/1 mL; 3.75 mg/1 mL; .1 mg/1 mL · injection, solution · reported period 2026-1
• Fentanyl Citrate · 50 ug/1 mL · injection, solution · reported period 2026-1
• Glycopyrrolate · .2 mg/1 mL · injection, solution · reported period 2026-1
• Hydromorphone · 1 mg/1 mL · injection, solution · reported period 2026-1
• Ketamine Hydrochloride · 10 mg/1 mL · injection, solution · reported period 2026-1
• Lidocaine Hydrochloride · 20 mg/1 mL · injection, solution · reported period 2026-1
• Lidocaine Hydrochloride · 10 mg/1 mL · injection, solution · reported period 2026-1
• Lidocaine Hydrochloride; Phenylephrine Hydrochloride · 10 mg/1 mL; 15 mg/1 mL · injection, solution · reported period 2026-1
• Midazolam Hydrochloride · 5 mg/1 mL · injection, solution · reported period 2026-1
• Morphine Sulfate · 5 mg/1 mL · injection, solution · reported period 2026-1
• Moxifloxacin Hydrochloride · 5 mg/1 mL · injection, solution · reported period 2026-1
• Moxifloxacin Hydrochloride · 1 mg/1 mL · injection, solution · reported period 2026-1
• Neostigmine Methylsulfate · 1 mg/1 mL · injection, solution · reported period 2026-1
• Phenylephrine Hydrochloride · 100 ug/1 mL · injection, solution · reported period 2026-1
• Phenylephrine Hydrochloride · 80 ug/1 mL · injection, solution · reported period 2026-1
• Rocuronium Bromide · 10 mg/1 mL · injection, solution · reported period 2026-1
• Ropivacaine Hydrochloride · 2 mg/1 mL · injection, solution · reported period 2026-1

Source: FDA outsourcing facility product reports (FD&C 503B(b)(2)). Retrospective by design: a row means the facility reported compounding this product to FDA in the named period, never that it currently compounds, can supply, or is endorsed for it. Public-record posture, not a determination.

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