Imprimis NJOF, LLC, Ledgewood

FDA 503B registration status

FDA 503B list ✓ (current 2026-07-14)

Imprimis NJOF, LLC, Ledgewood appears on FDA's registered outsourcing facilities list, parsed from Veritura's capture of that list (FDA list current as of 2026-07-14, captured 2026-07-17). 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 2026-07-17 capture (FDA list current as of 2026-07-14).

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

8 dated enforcement records matched this firm name in openFDA when this check last completed.

• 2025-12-18 · drug · Class II · Ongoing
  Presence of particulate matter - Glass like particles.
• 2025-07-09 · drug · Class III · Completed
  Sub-Potent Drug: Subpotent assay results during stability testing.
• 2024-05-14 · drug · Class II · Ongoing
  Lack of Assurance of Sterility
• 2024-05-14 · drug · Class II · Ongoing
  Lack of Assurance of Sterility
• 2024-05-14 · drug · Class II · Ongoing
  Lack of Assurance of Sterility
• 2024-04-10 · drug · Class II · Ongoing
  Subpotent Drug
• 2024-04-10 · drug · Class III · Ongoing
  Out of specification for assay
• 2020-12-17 · drug · Class II · Terminated
  Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.

Source: openFDA enforcement records (drug/device/food, updated weekly), checked 2026-07-18. 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

8 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: Imprimis NJOF, LLC, Ledgewood); it is not a Veritura determination about the facility.

Reported products

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

• Atropine Sulfate · .1 mg/1 mL · solution/ drops · reported period 2025-2
• Atropine Sulfate · .25 mg/1 mL · solution/ drops · reported period 2025-2
• Atropine Sulfate · .5 mg/1 mL · solution/ drops · reported period 2025-2
• Azithromycin Dihydrate · 10 mg/1 mL · solution/ drops · reported period 2025-2
• Bimatoprost · .1 mg/1 mL · solution/ drops · reported period 2025-2
• Bromfenac Sodium; Prednisolone Acetate · .75 mg/1 mL; 10 mg/1 mL · suspension/ drops · reported period 2025-2
• Cyclopentolate Hydrochloride; Phenylephrine Hydrochloride; Tropicamide · 10 mg/1 mL; 25 mg/1 mL; 10 mg/1 mL · solution/ drops · reported period 2025-2
• Cyclosporine · 1 mg/1 mL · emulsion · reported period 2025-2
• Dexamethasone Sodium Phosphate; Moxifloxacin Hydrochloride; Ketorolac Tromethamine · 1 mg/1 mL; .5 mg/1 mL; .4 mg/1 mL · injection, solution · reported period 2025-2
• Dorzolamide Hydrochloride · 20 mg/1 mL · solution/ drops · reported period 2025-2
• Dorzolamide Hydrochloride; Bimatoprost; Timolol Maleate · 20 mg/1 mL; .1 mg/1 mL; 5 mg/1 mL · solution/ drops · reported period 2025-2
• Dorzolamide Hydrochloride; Brimonidine · 20 mg/1 mL; 1.5 mg/1 mL · solution/ drops · reported period 2025-2
• Lidocaine Hydrochloride; Epinephrine Bitartrate · 7.5 mg/1 mL; .25 mg/1 mL · injection, solution · reported period 2025-2
• Lidocaine Hydrochloride; Epinephrine Hydrochloride · 7.5 mg/1 mL; .25 mg/1 mL · injection, solution · reported period 2025-2
• Loteprednol Etabonate · 5 mg/1 mL · solution/ drops · reported period 2025-2
• Moxifloxacin Hydrochloride · 4 mg/.8 mL · injection, solution · reported period 2025-2
• Moxifloxacin Hydrochloride · .8 mg/.8 mL · injection, solution · reported period 2025-2
• Moxifloxacin Hydrochloride; Bromfenac Sodium · 5 mg/1 mL; .75 mg/1 mL · solution/ drops · reported period 2025-2
• Moxifloxacin Hydrochloride; Dexamethasone Sodium Phosphate · 5 mg/1 mL; 1 mg/1 mL · injection, solution · reported period 2025-2
• Moxifloxacin Hydrochloride; Prednisolone Sodium Phosphate; Bromfenac Sodium · 5 mg/1 mL; 10 mg/1 mL; .75 mg/1 mL · solution/ drops · reported period 2025-2

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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