Pine Pharmaceuticals, LLC

The FDA's record of Pine Pharmaceuticals, LLC of Tonawanda, NY, a registered 503B outsourcing facility: its registration dates and its inspection record.

Checked against the FDA registered outsourcing facilities list on Oct 25, 2026. See the list on fda.gov

503B outsourcing facilityLast inspection Nov 14, 2025

Pine Pharmaceuticals, LLC of Tonawanda, New York is on the FDA’s list of facilities registered as human drug compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act. The FDA says the list includes the facilities whose registration information it has determined to be complete.1

The list dates its last inspection Nov 14, 2025. The FDA dates an inspection by the day it issued a Form FDA 483, or, where it issued none, by the last day of the inspection.1

Action based on the last inspection, as the list states it: “Warning Letter Issued 8/7/2026”.1

The record

What the FDA register shows

Column	What the register shows	Source
Facility	Pine Pharmaceuticals, LLC, Tonawanda, NY	FDA register
Initial registration date	Mar 9, 2018	FDA register
Most recent registration date	Oct 9, 2026	FDA register
Last inspection	Nov 14, 2025	FDA register
Form 483 issued?	Yes: read the Form 483 on fda.gov	FDA register
Recall conducted?	No	FDA register
Action based on last inspection	Warning Letter Issued 8/7/2026	FDA register
Intends to compound sterile drugs from bulk substances	Yes	Stated by the facility at registration; not verified by the FDA

A Form FDA 483 lists conditions an FDA investigator observed during an inspection that in their judgment may be violations. The FDA says it is not a final agency determination of whether any condition is a violation.2

How a 503B outsourcing facility differs from a 503A pharmacy: 503A vs 503B.

This page restates public FDA records as they stood on the check date above. It is not legal or medical advice.

503A vs 503B Pharmacies: What FDA's Inspection Record Shows

56 of 57 inspected 503B facilities received a Form 483

Data sources

1.
FDA registered outsourcing facilitiesU.S. Food and Drug Administrationretrieved Oct 25, 2026↩
2.
FDA Form 483 frequently asked questionsU.S. Food and Drug Administration↩
3.
Form FDA 483 issued to Pine Pharmaceuticals, LLCU.S. Food and Drug Administration