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•United States

Wedgewood Connect, LLC, San Jose, CA – FDA Inspections

Inspection records and compliance data for Wedgewood Connect, LLC in San Jose, California. 8 FDA inspections on record (3 OAI), 4 Form 483s, 1 warning letter, last inspected July 03, 2025.

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Company Profile

This profile covers Wedgewood Connect, LLC based in San Jose, California, United States.

FDA Inspection History

FDA inspections
8
OAI
3
VAI
5
NAI
0
Form 483s
4
Warning letters
1

First inspected November 5, 2013. Last inspected July 3, 2025.

Most cited issue areas

  • Procedures for sterile drug products6 inspections
  • Cleaning System3 inspections
  • Environmental Monitoring System3 inspections

FDA inspections (8)

DateResultFDA center(s)Insp. #
July 3, 2025VAIHuman Drugs · Drug Quality Assurance1275280
November 17, 2023VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance1224880
December 3, 2021VAIHuman Drugs · Drug Quality Assurance1158151
December 19, 2018VAIHuman Drugs · Drug Quality Assurance1076909
June 15, 2017VAIHuman Drugs · Drug Quality Assurance1014307
October 7, 2014OAIHuman Drugs · Drug Quality Assurance902151
March 6, 2014OAIHuman Drugs · Drug Quality Assurance870667
November 5, 2013OAIHuman Drugs · Drug Quality Assurance855641
FDA documents

Form 483s (9)

  • Form 483s · July 3, 2025
  • Form 483s · November 17, 2023
  • Form 483s · November 17, 2023
  • Form 483s · December 3, 2021
  • Form 483s · December 19, 2018
  • Form 483s · June 15, 2017
  • Form 483s · October 7, 2014
  • Form 483s · March 6, 2014
  • Form 483s · November 5, 2013

Warning Letters (5)

  • Warning Letters · November 17, 2023
  • Warning Letters · November 17, 2023
  • Warning Letters · November 17, 2023
  • Warning Letters · November 9, 2023
  • Warning Letters · March 6, 2014
People (6)
Lance M. De Souza
Person
Marcy Bliss
Person
Kathleen M. Lewis
Person
Russell A. Campbell
Person
Jolanna A. Norton
Person
Lisa Shin
Person
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Diane Highum, M.D.
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Tower Pharmacy and Compounding
U.S. Continental Marketing, Inc.
Company Information

Name

Wedgewood Connect, LLC

FEI Number

3003434972

Address

17 Great Oaks Blvd, San Jose, California 95119, United States

Country

United States

ID: 26eedeaf-d44e-48a5-b4c3-8b28c9b361ff

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Contact
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