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FDA register as of 2026-09-02
Pine Pharmaceuticals, LLC
Pine Pharmaceuticals, LLC, Tonawanda, NY, is registered with the FDA as a 503B outsourcing facility (first registered 3/9/2018; most recent registration 11/19/2025). The FDA last inspected it on 11/14/2025; a Form 483 was issued, a recall was not conducted, and the action recorded is “Warning Letter Issued 8/7/2026”.
- Status
- 503B REGISTERED
- Location
- Tonawanda, NY
- First registration
- 3/9/2018
- Most recent registration
- 11/19/2025
- Last FDA inspection
- 11/14/2025
- Form 483 issued
- Yes · read the 483
- Recall conducted
- No
- Action based on last inspection
- Warning Letter Issued 8/7/2026
- Compounds sterile drugs from bulk
- Yes
- Contact listed by the FDA
- Alfonse Muto · 716-248-1025
How to read this record
Registration means the facility has registered with the FDA under section 503B and is subject to FDA inspection under current good manufacturing practice. It is not an endorsement. A Form 483 is the list of observations an investigator leaves at the end of an inspection; it is not a finding of violation, and most inspected facilities on the register have received one. “Open” means the FDA has not finalised the inspection's classification. A regulatory meeting or a warning letter is a further step, and the FDA posts the letter, which we link when it does.
What this page does not tell you: whether a specific drug from this facility is right for you, or whether the telehealth brand that sold it to you is the same entity. Compounded prescriptions are labelled with the pharmacy that made them — compare that label to this name.
Other registered facilities in New York
The FDA lists 2 registered 503B facilities in New York. Their records, and the state's 503A pharmacies: compounding pharmacies in New York.
- Galaxy Pharmaceuticals, LLC · Albany
Source: FDA — Registered Outsourcing Facilities, as of 2026-09-02; every value above is the FDA's, reproduced without characterisation. Back to the full register, or look up another pharmacy.