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FDA register as of 2026-10-13 · Compiled and edited by Darrel Donaghy
503B outsourcing facilities in New Jersey
The FDA lists 8 registered 503B outsourcing facilities in New Jersey as of 2026-10-13: 4 inspected, 4 with a Form 483, 0 with a warning letter or equivalent action. The most recent FDA inspection among them is dated 8/18/2026, at Imprimis NJOF, LLC in Ledgewood.
New Jersey's 503B facilities at a glance
- Where they are
- Bloomsbury, Buena, East Windsor, Hackettstown, Ledgewood, Mt. Laurel, New Providence, Somerset
- Most recent FDA inspection
- 8/18/2026 at Imprimis NJOF, LLC, Ledgewood · action: Open
- Not yet inspected
- 4 of 8
- Registered with the FDA
- Earliest: Imprimis NJOF, LLC, 11/12/2016. Newest: Hyalo Technologies Limited Liability Company, 5/1/2025.
- Recall conducted
- 0 of 8, per the FDA's recall column
- Intend to compound sterile drugs from bulk substances
- 8 of 8, per the FDA's column of that name
The FDA's record for each New Jersey facility
| Facility | First registered | Last FDA inspection | Form 483 | Recall | Action |
|---|---|---|---|---|---|
| Denver Solutions, LLC, dba Leiters Health Buena, NJ | 7/1/2022 | Not yet inspected | — | — | No inspection yet |
| Empower Clinic Services New Jersey East Windsor, NJ | 6/10/2024 | Not yet Inspected | — | — | No inspection yet |
| Hyalo Technologies Limited Liability Company Somerset, NJ | 5/1/2025 | Not yet inspected | — | — | No inspection yet |
| Imprimis NJOF, LLC Ledgewood, NJ | 11/12/2016 | 8/18/2026 | Yes | No | Open |
| Molecular PharmaGroup New Providence, NJ | 5/8/2018 | 8/11/2025 | Yes (483) | No | Untitled Letter Issued 2/5/2026 |
| Quva Pharma, Inc. Bloomsbury, NJ | 9/15/2017 | 4/4/2025 | Yes (483) | No | Open |
| Sankav Pharmaceuticals, LLC Hackettstown, NJ | 3/21/2025 | Not yet inspected | — | — | No inspection yet |
| Stokes Healthcare Inc., dba Epicur Pharma Mt. Laurel, NJ | 1/30/2018 | 5/23/2025 | Yes (483) | No | Open |
Compounding pharmacies in New Jersey that are not on this list
New Jersey's 503A pharmacies are licensed by the state board of pharmacy, not registered with the FDA, so they never appear here. Their record is the board's license lookup (NABP directory of boards). 503A vs 503B, explained.
Source: FDA — Registered Outsourcing Facilities, dated 2026-10-13. “Open” is an unfinalised classification, not a finding. Other states (16) · look up a pharmacy by name.