Pine Pharmaceuticals, LLC
Form 483 issued November 14, 2025 · Tonawanda, New York
- Inspection
- Nov 4 – Nov 14, 2025
- Investigators
- Anna M. Spiros· Jordan S. Burkdoll· Logan T. Williams
- Observations
- 5
- Pages
- 8
- FEI number
- 3010943533
In short: On November 14, 2025, FDA issued a Form 483 with 5 observations to Pine Pharmaceuticals, LLC in Tonawanda, New York (FEI 3010943533) after an inspection that ran Nov 4 – Nov 14, 2025. The investigators were Anna M. Spiros, Jordan S. Burkdoll and Logan T. Williams. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Employees engaged in the processing of a drug product lack the training required to…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Anna M. Spiros
6 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Michigan.
The firmPine Pharmaceuticals, LLC history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pine Pharmaceuticals, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Pine Pharmaceuticals, LLC?
Anna M. Spiros, Jordan S. Burkdoll and Logan T. Williams are named on this Form 483, for the inspection of Nov 4 – Nov 14, 2025. Each investigator has a profile showing what they cite most.
When was Pine Pharmaceuticals, LLC inspected by FDA?
The inspection ran Nov 4 – Nov 14, 2025, and the Form 483 is dated November 14, 2025.
How do I get the full Form 483 for Pine Pharmaceuticals, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.