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Llorens Pharmaceuticals International Division, Inc., Miami, FL – FDA Inspections

Inspection records and compliance data for Llorens Pharmaceuticals International Division, Inc. in Miami, Florida. 8 FDA inspections on record (1 OAI), 3 Form 483s, last inspected September 26, 2025.

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Company Profile

This profile covers Llorens Pharmaceuticals International Division, Inc. based in Miami, Florida, United States.

FDA Inspection History

FDA inspections
8
OAI
1
VAI
6
NAI
1
Form 483s
3
Warning letters
0

First inspected September 30, 2010. Last inspected September 26, 2025.

Most cited issue areas

  • Procedures not in writing, fully followed3 inspections
  • Adequate lab facilities not available1 inspection
  • Adverse Drug Experience1 inspection

FDA inspections (8)

DateResultFDA center(s)Insp. #
September 26, 2025VAIFoods & Cosmetics · Food Composition, Standards, Labeling, and Economics1229574
May 15, 2025VAIHuman Drugs · Drug Quality Assurance1258728
March 11, 2020VAIHuman Drugs · Drug Quality Assurance1120499
August 29, 2019VAIFoods & Cosmetics · Food Composition, Standards, Labeling and Econ1100710
July 12, 2016VAIFoods & Cosmetics · Food Composition, Standards, Labeling and Econ979515
May 22, 2012NAIFoods & Cosmetics · Food Composition, Standards, Labeling and Econ783137
August 1, 2011VAIFoods & Cosmetics, Human Drugs · Drug Quality Assurance738229
September 30, 2010OAIFoods & Cosmetics, Human Drugs · Drug Quality Assurance678287
FDA documents

Form 483s (3)

  • Form 483s · May 15, 2025
  • Form 483s · March 11, 2020
  • Form 483s · August 29, 2019

EIRs (2)

  • EIRs · March 11, 2020
  • EIRs · August 20, 2019
People (4)
Jose C. Llorens
Person
Reynaldo G. Farinas
Person
Lissette Paiz
Person
Joanne E. King
Person
Related Companies (10)

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

Pharmco Laboratories Inc.
Mission Pharmacal Company
Vee Pak, LLC
Denison Pharmaceuticals, LLC
Hospira, Inc., A Pfizer Company
Patheon Manufacturing Services LLC
Radienz Living LLC
Catalent Belgium SA
Haleon US Inc.
Afton Scientific, LLC
Company Information

Name

Llorens Pharmaceuticals International Division, Inc.

FEI Number

3008468946

Address

7080 Nw 37th Ct, Miami, Florida 33147, United States

Country

United States

ID: 3bc4594c-275f-4451-9cf8-4e2e9bc14ee4

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