503B Docket

Imprimis NJOF, LLC 503B outsourcing facility · Ledgewood, NJ

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 asImprimis NJOF, LLC, Ledgewood, NJ
City / stateLedgewood, NJ
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)973-328-8756
Initial registration date11/12/2016
Most recent registration date11/26/2025
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)8/18/2026
Form 483 issued at last inspection?Yes
Recall conducted? (FDA table)No
Action based on last inspectionOpen
“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.
Prior compounding inspection history flagYes
FDA footnotes this facility as the subject of at least one previous compounding inspection that resulted in a Form 483, warning letter or other action.

Source: FDA Registered Outsourcing Facilities

Published FDA records

3Form 483 records
1Warning letters
14Recall 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

New Jersey Board of Pharmacy License Verification (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. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: Yes
    No document link published · FDA registered outsourcing facilities table
  2. Form FDA 483 FDA table
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published · FDA registered outsourcing facilities table
  3. Recall Matched
    Recall event 98181
    Class II · Ongoing · 3 product line(s) · Recall no. D-0249-2026, D-0250-2026, D-0251-2026
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Presence of particulate matter - Glass like particles.
    openFDA record · openFDA drug enforcement API
  4. Recall Matched
    Recall event 97824
    Class III · Ongoing · 1 product line(s) · Recall no. D-0157-2026
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Subpotent Drug
    openFDA record · openFDA drug enforcement API
  5. Recall Matched
    Recall event 97183
    Class II, Class III · Completed · 2 product line(s) · Recall no. D-0535-2025, D-0536-2025
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Sub-Potent Drug: Subpotent assay results during stability testing.
    openFDA record · openFDA drug enforcement API
  6. Recall Matched
    Recall event 96329
    Class III · Ongoing · 1 product line(s) · Recall no. D-0305-2025
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
    openFDA record · openFDA drug enforcement API
  7. Recall Matched
    Recall event 94552
    Class II · Ongoing · 1 product line(s) · Recall no. D-0548-2024
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  8. Recall Matched
    Recall event 94551
    Class II · Ongoing · 5 product line(s) · Recall no. D-0512-2024, D-0513-2024, D-0514-2024, D-0515-2024, D-0516-2024
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  9. Recall Matched
    Recall event 94553
    Class II · Ongoing · 1 product line(s) · Recall no. D-0519-2024
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  10. Recall Matched
    Recall event 94554
    Class II · Ongoing · 1 product line(s) · Recall no. D-0547-2024
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  11. Recall Matched
    Recall event 94378
    Class II · Ongoing · 1 product line(s) · Recall no. D-0476-2024
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Subpotent Drug
    openFDA record · openFDA drug enforcement API
  12. Recall Matched
    Recall event 94372
    Class III · Ongoing · 1 product line(s) · Recall no. D-0478-2024
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Out of specification for assay
    openFDA record · openFDA drug enforcement API
  13. Form FDA 483 Matched
    483 Issued 04/03/2024 (PDF - 3.21MB)
    Listed on FDA page under: Imprimis NJOF, LLC, Ledgewood, NJ - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  14. Recall Matched
    Recall event 93160
    Class III · Terminated · 1 product line(s) · Recall no. D-0040-2024
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Subpotent: Failing Test Results for Epinephrine
    openFDA record · openFDA drug enforcement API
  15. Recall Matched
    Recall event 93093
    Class III · Terminated · 1 product line(s) · Recall no. D-0043-2024
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
    openFDA record · openFDA drug enforcement API
  16. Recall Matched
    Recall event 92848
    Class III · Terminated · 1 product line(s) · Recall no. D-1094-2023
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
    openFDA record · openFDA drug enforcement API
  17. Form FDA 483 Matched
    483 Issued 01/29/2021 (PDF - 5.35MB)
    Listed on FDA page under: Imprimis NJOF, LLC, Ledgewood, NJ - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  18. Recall Matched
    Recall event 87029
    Class II · Terminated · 1 product line(s) · Recall no. D-0177-2021
    Recalling firm as listed: Imprimis NJOF, LLC, Ledgewood, NJ. Reason: Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
    openFDA record · openFDA drug enforcement API
  19. Warning letter Matched
    Warning Letter (06/07/2019)
    Listed on FDA page under: Imprimis NJOF, LLC, Ledgewood, NJ - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions