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•United States

Pine Pharmaceuticals, LLC, Tonawanda, NY – FDA Inspections

Inspection records and compliance data for Pine Pharmaceuticals, LLC in Tonawanda, New York. 7 FDA inspections on record (4 OAI), 4 Form 483s, 1 warning letter, last inspected November 14, 2025.

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Company Profile

This profile covers Pine Pharmaceuticals, LLC based in Tonawanda, New York, United States.

FDA Inspection History

FDA inspections
7
OAI
4
VAI
1
NAI
1
Unclassified
1
Form 483s
4
Warning letters
1

First inspected October 17, 2014. Last inspected November 14, 2025.

Most cited issue areas

  • Procedures for sterile drug products4 inspections
  • Investigations of discrepancies, failures3 inspections
  • Absence of Written Procedures1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
November 14, 2025Not classifiedHuman Drugs1282102
September 30, 2024OAIHuman Drugs · Drug Quality Assurance1246936
September 19, 2023OAIHuman Drugs · Drug Quality Assurance1218206
May 14, 2021OAIHuman Drugs · Drug Quality Assurance1141929
April 26, 2018VAIHuman Drugs · Drug Quality Assurance1049641
October 9, 2015OAIHuman Drugs · Drug Quality Assurance945292
October 17, 2014NAIHuman Drugs · Drug Quality Assurance900138
FDA documents

Form 483s (6)

  • Form 483s · November 4, 2025
  • Form 483s · September 30, 2024
  • Form 483s · September 19, 2023
  • Form 483s · May 14, 2021
  • Form 483s · April 26, 2018
  • Form 483s · October 9, 2015

Warning Letters (1)

  • Warning Letters · November 14, 2025
People (4)
James A. Liubicich
Person
Mindy M. Chou
Person
Rachael A. Moliver
Person
Johnna L. Bleem
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Ohm Laboratories, Inc.
Michael T. Lin, M.D.
J. John Mann, M.D.
Park Irmat Drug Corp., dba Irmat Pharmacy
Jonathan E. Rosenberg, MD
Rogerio Lobo
Athenex, Inc.
Arnot Health IRB
Scott Bloom, M.D.
Jens Hillengass, M.D., Ph.D.
Company Information

Name

Pine Pharmaceuticals, LLC

FEI Number

3010943533

Address

355 Riverwalk Pkwy, Tonawanda, New York 14150, United States

Country

United States

ID: 03870efc-b074-462a-8520-e5cadc945149

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