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•United States

Acino Products, LLC, Trenton, NJ – FDA Inspections

Inspection records and compliance data for Acino Products, LLC in Trenton, New Jersey. 10 FDA inspections on record (6 OAI), 3 Form 483s, 1 warning letter, last inspected May 21, 2025.

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Company Profile

This profile covers Acino Products, LLC based in Trenton, New Jersey, United States.

FDA Inspection History

FDA inspections
10
OAI
6
VAI
1
NAI
2
Unclassified
1
Form 483s
3
Warning letters
1

First inspected June 13, 2013. Last inspected May 21, 2025.

Most cited issue areas

  • Procedures not in writing, fully followed4 inspections
  • Items to cover on annual reviews3 inspections
  • Absence of Written Procedures2 inspections

FDA inspections (10)

DateResultFDA center(s)Insp. #
May 21, 2025OAIHuman Drugs · Drug Quality Assurance1270811
August 30, 2024OAIHuman Drugs · Drug Quality Assurance1248550
June 12, 2019Not classifiedHuman Drugs · Unapproved and Misbranded Drugs1092674
November 14, 2017VAIHuman Drugs · Drug Quality Assurance1032468
November 22, 2016NAIHuman Drugs · Drug Quality Assurance993200
October 26, 2015OAIHuman Drugs · Unapproved and Misbranded Drugs949868
January 21, 2015OAIHuman Drugs · Unapproved and Misbranded Drugs911866
August 19, 2014OAIHuman Drugs · Drug Quality Assurance891224
March 5, 2014OAIHuman Drugs · Unapproved and Misbranded Drugs865640
June 13, 2013NAIHuman Drugs · Drug Quality Assurance835646
FDA documents

Form 483s (4)

  • Form 483s · May 21, 2025
  • Form 483s · August 30, 2024
  • Form 483s · July 1, 2021
  • Form 483s · June 12, 2019

Warning Letters (1)

  • Warning Letters · June 12, 2019
People (4)
Russell J. Glapion
Person
Diana Amador-Toro
Person
Daniel J. Min
Person
David A. Oluwo
Person
Related Companies (10)

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Alvogen, Inc
Liberty Drug & Surgical
Fairy Tales Hair Care Inc.
Martin E. Gutierrez
Merck, Inc.
Vinay Sikand, M.D.
Braeburn Pharmaceuticals Inc.
Company Information

Name

Acino Products, LLC

FEI Number

3004723334

Address

32 Tally Rd, Trenton, New Jersey 08619, United States

Country

United States

ID: 8499d0c9-9cf4-432b-96dd-6e7c087fa70f

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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