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•United States

CoreRX Inc., Clearwater, FL – FDA Inspections

Inspection records and compliance data for CoreRX Inc. in Clearwater, Florida. 9 FDA inspections on record, 6 Form 483s, last inspected February 26, 2026.

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Company Profile

This profile covers CoreRX Inc. based in Clearwater, Florida, United States.

FDA Inspection History

FDA inspections
9
OAI
0
VAI
5
NAI
1
Unclassified
3
Form 483s
6
Warning letters
0

First inspected June 19, 2015. Last inspected February 26, 2026.

Most cited issue areas

  • Absence of Written Procedures2 inspections
  • Annual visual exams of drug products1 inspection
  • Buildings not maintained in good state of repair1 inspection

FDA inspections (9)

DateResultFDA center(s)Insp. #
February 26, 2026Not classifiedHuman Drugs · Drug Quality Assurance1304588
March 20, 2025Not classifiedBiologics · Vaccine, Allergenic, and Live Biotherapeutic Products1264769
August 13, 2021NAIHuman Drugs · Drug Quality Assurance1151289
March 6, 2020VAIHuman Drugs · Drug Quality Assurance1119912
June 21, 2019VAIHuman Drugs · Generic Drug Evaluation1094038
June 14, 2019Not classifiedBiologics1105141
September 27, 2017VAIHuman Drugs · Drug Quality Assurance1027540
November 10, 2016VAIHuman Drugs · Generic Drug Evaluation992071
June 19, 2015VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices932712
FDA documents

Form 483s (6)

  • Form 483s · February 26, 2026
  • Form 483s · March 20, 2025
  • Form 483s · March 6, 2020
  • Form 483s · June 21, 2019
  • Form 483s · June 14, 2019
  • Form 483s · January 24, 2014
People (6)
Mizanne E. Lewis
Person
Michael H. Tollon
Person
Jennifer Bridgewater, Assoc. Dir. for Reg. Policy
Person
Philippa Hillyer, Staff Fellow
Person
Naveen B Kanthamneni
Person
Jose F. Velez
Person
Related Companies (10)

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

Afton Scientific, LLC
Bora Pharmaceuticals Injectables Inc
Patheon Manufacturing Services LLC
Jubilant HollisterStier LLC
Hospira, Inc., A Pfizer Company
Janssen Pharmaceuticals Inc.
Catalent Belgium SA
Pfizer Manufacturing Belgium NV
Cipla Limited
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
Company Information

Name

CoreRX Inc.

FEI Number

3007209985

Address

14205 Myerlake Cir, Clearwater, Florida 33760, United States

Country

United States

ID: cca4f858-9ccd-498a-893b-22c5d29559aa

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Contact
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370 Jay Street 7th Floor
Brooklyn, NY 11201
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201 Lackawanna Avenue
Scranton, PA, 18503
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🇪🇺+48 532-447-507
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