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Company
•United States

InvaDerm, Inc., Somerset, NJ – FDA Inspections

Inspection records and compliance data for InvaDerm, Inc. in Somerset, New Jersey. 5 FDA inspections on record, 5 Form 483s, 1 warning letter, last inspected October 17, 2024.

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Company Profile

This profile covers InvaDerm, Inc. based in Somerset, New Jersey, United States.

FDA Inspection History

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

First inspected May 30, 2017. Last inspected October 17, 2024.

Most cited issue areas

  • Equipment Design, Size and Location2 inspections
  • Items to cover on annual reviews2 inspections
  • Procedures not in writing, fully followed2 inspections

FDA inspections (5)

DateResultFDA center(s)Insp. #
October 17, 2024Not classifiedHuman Drugs · Drug Quality Assurance1252311
June 28, 2023VAIHuman Drugs · Drug Quality Assurance1210509
March 26, 2019VAIHuman Drugs · Drug Quality Assurance1084054
June 15, 2017VAIHuman Drugs · Drug Quality Assurance1014690
May 30, 2017VAIHuman Drugs · Drug Quality Assurance1011953
FDA documents

Form 483s (2)

  • Form 483s · October 17, 2024
  • Form 483s · June 28, 2023

Warning Letters (1)

  • Warning Letters · October 17, 2024
People (4)
James R. Birkenstamm
Person
David A. Oluwo
Person
Dilip Solanki, CEO
Person
Tina Smith
Person
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Company Information

Name

InvaDerm, Inc.

FEI Number

3010165760

Address

25 Worlds Fair Dr, Somerset, New Jersey 08873, United States

Country

United States

ID: 33416b4a-1d16-4adf-987e-d5970ac5f9a2

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