Imprimis NJOF, LLC
FDA 503B outsourcing facility
Ledgewood, New Jersey
Key Takeaways
- FDA-registered 503B outsourcing facility since 2016
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: April 3, 2024
- FDA action: Regulatory Meeting Held 10/21/2025
- 21 FDA drug recalls on record (2020 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
- November 12, 2016
- Most recent registration
- November 26, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- April 3, 2024
The FDA last inspected Imprimis NJOF, LLC on April 3, 2024. Investigators issued a Form FDA 483 listing inspectional observations at that visit. FDA action on record: Regulatory Meeting Held 10/21/2025.
FDA recall history
Imprimis NJOF, LLC has 21 FDA drug recalls on record between 2020 and 2025, based on the FDA enforcement database. Breakdown: 14 Class II, 7 Class III.
Recall reasons on record include presence of particulate matter - glass like particles; subpotent drug; sub-potent drug: subpotent assay results during stability testing; sub-potent drug: the stability batch showed a subpotent result, which does not meet the; lack of assurance of sterility.
| Date | Class | Product | Reason |
|---|---|---|---|
| December 2025 | Class II | Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West | Presence of particulate matter - Glass like particles. |
| December 2025 | Class II | Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 | Presence of particulate matter - Glass like particles. |
| December 2025 | Class II | Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-5 | Presence of particulate matter - Glass like particles. |
| October 2025 | Class III | Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottl | Subpotent Drug |
| July 2025 | Class III | Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Impri | Sub-Potent Drug: Subpotent assay results during stability testing. |
Showing the 5 most recent of 21 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.
What this facility compounds
Imprimis NJOF, LLC reports compounding 33 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Atropine Sulfate
- Azithromycin Dihydrate
- Bimatoprost
- Bromfenac Sodium; Prednisolone Acetate
- Cyclopentolate Hydrochloride; Phenylephrine Hydrochloride; Tropicamide
- Cyclosporine
- Dexamethasone Sodium Phosphate; Moxifloxacin Hydrochloride; Ketorolac Tromethamine
- Dorzolamide Hydrochloride
- Dorzolamide Hydrochloride; Bimatoprost; Timolol Maleate
- Dorzolamide Hydrochloride; Brimonidine
- Lidocaine Hydrochloride; Epinephrine Bitartrate
- Lidocaine Hydrochloride; Epinephrine Hydrochloride
- Loteprednol Etabonate
- Moxifloxacin Hydrochloride
- Moxifloxacin Hydrochloride; Bromfenac Sodium
- Moxifloxacin Hydrochloride; Dexamethasone Sodium Phosphate
- Moxifloxacin Hydrochloride; Prednisolone Sodium Phosphate; Bromfenac Sodium
- Moxifloxacin Hydrochloride; Triamcinolone Acetonide
- Nepafenac; Prednisolone Acetate
- Nepafenac; Prednisolone Acetate; Moxifloxacin Hydrochloride
- Ondansetron Hydrochloride; Ketamine Hydrochloride; Midazolam
- Phenylephrine Hydrochloride; Lidocaine Hydrochloride
- Phenylephrine Hydrochloride; Tropicamide
- Phenylephrine Hydrochloride; Tropicamide; Proparacaine Hydrochloride; Ketorolac Tromethamine
- Prednisolone Acetate
- Prednisolone Acetate; Moxifloxacin Hydrochloride
- Prednisolone Acetate; Moxifloxacin Hydrochloride; Bromfenac Sodium
- Proparacaine Hydrochloride; Povidone-Iodine
- Timolol Maleate; Bimatoprost
- Timolol Maleate; Dorzolamide Hydrochloride; Brimonidine
and 3 more.
Location
1705 Route 46 Ste 6B, Ledgewood, NJ 07852-9720
Satellite and street imagery via Esri. Open larger map.
Contact
FDA-registered contact: Fred Weiss Ext=5411, 973-328-8756. 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 Imprimis NJOF, LLC with the New Jersey Board of Pharmacy.
503B facilities in New Jersey
New Jersey has 10 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in New Jersey.
Frequently asked questions
Is Imprimis NJOF, LLC registered with the FDA?
Yes. Imprimis NJOF, LLC is a registered 503B outsourcing facility, first registered with the FDA on November 12, 2016 and most recently registered on November 26, 2025.
Has Imprimis NJOF, LLC been inspected by the FDA?
The FDA last inspected Imprimis NJOF, LLC on April 3, 2024. A Form FDA 483 was issued. FDA action on record: Regulatory Meeting Held 10/21/2025.
Has Imprimis NJOF, LLC had any FDA drug recalls?
Imprimis NJOF, LLC has 21 FDA drug recalls on record (2020 to 2025) in the FDA enforcement database.
What does Imprimis NJOF, LLC compound?
Imprimis NJOF, LLC reports compounding 33 active ingredients to the FDA.
Where is Imprimis NJOF, LLC located?
Imprimis NJOF, LLC is located in Ledgewood, New Jersey (1705 Route 46 Ste 6B).
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 Imprimis NJOF, LLC. 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.