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•United States

Rockledge Pharmaceutical Manufacturing LLC, Rockledge, FL – FDA Inspections

Inspection records and compliance data for Rockledge Pharmaceutical Manufacturing LLC in Rockledge, Florida. 5 FDA inspections on record, 2 Form 483s, last inspected April 24, 2025.

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Company Profile

This profile covers Rockledge Pharmaceutical Manufacturing LLC based in Rockledge, Florida, United States.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
5
NAI
0
Form 483s
2
Warning letters
0

First inspected July 16, 2009. Last inspected April 24, 2025.

Most cited issue areas

  • Scientifically sound laboratory controls1 inspection
  • Written record of investigation incomplete1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
April 24, 2025VAIHuman Drugs · Drug Quality Assurance1250752
January 25, 2019VAIHuman Drugs · Drug Quality Assurance1077088
May 19, 2016VAIHuman Drugs · Drug Quality Assurance973786
June 20, 2013VAIHuman Drugs · Drug Quality Assurance838341
July 16, 2009VAIHuman Drugs · Drug Quality Assurance597735
FDA documents

Form 483s (1)

  • Form 483s · April 24, 2025
Other regulators (1)
  • UK MHRA · 3 inspections · last June 12, 2017
People (1)
Angelica M. Hernandez
Person
Related Companies (10)

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Lead Chemical Co., Ltd.
Noven Pharmaceuticals Inc
Tedor Pharma, Inc.
Murty Pharmaceuticals, Inc
Agnitio Inc
Zydus Lifesciences Limited
Pharmaceutical Manufacturing Research Services, Inc (PMRS)
Playtex Manufacturing, Inc. - Plant #2
Company Information

Name

Rockledge Pharmaceutical Manufacturing LLC

FEI Number

1000113139

Address

417 Richard Rd, Rockledge, Florida 32955, United States

Country

United States

ID: a5456e96-65d2-4f19-ba2f-e7cb72b32922

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