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FDA register as of 2026-10-13 · Compiled and edited by Darrel Donaghy
503B outsourcing facilities in New York
The FDA lists 2 registered 503B outsourcing facilities in New York as of 2026-10-13: 1 inspected, 1 with a Form 483, 1 with a warning letter or equivalent action. The most recent FDA inspection among them is dated 11/14/2025, at Pine Pharmaceuticals, LLC in Tonawanda.
New York's 503B facilities at a glance
- Where they are
- Albany, Tonawanda
- Most recent FDA inspection
- 11/14/2025 at Pine Pharmaceuticals, LLC, Tonawanda · action: Warning Letter Issued 8/7/2026
- Not yet inspected
- 1 of 2
- Registered with the FDA
- Earliest: Pine Pharmaceuticals, LLC, 3/9/2018. Newest: Galaxy Pharmaceuticals, LLC, 1/26/2024.
- Recall conducted
- 0 of 2, per the FDA's recall column
- Intend to compound sterile drugs from bulk substances
- 1 of 2, per the FDA's column of that name
The FDA's record for each New York facility
| Facility | First registered | Last FDA inspection | Form 483 | Recall | Action |
|---|---|---|---|---|---|
| Galaxy Pharmaceuticals, LLC Albany, NY | 1/26/2024 | Not yet inspected | — | — | No inspection yet |
| Pine Pharmaceuticals, LLC Tonawanda, NY | 3/9/2018 | 11/14/2025 | Yes (483) | No | Warning Letter Issued 8/7/2026 |
Compounding pharmacies in New York that are not on this list
New York'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.