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•United States

Innogenix, LLC., Amityville, NY – FDA Inspections

Inspection records and compliance data for Innogenix, LLC. in Amityville, New York. 3 FDA inspections on record, 1 Form 483, last inspected March 13, 2025.

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Company Profile

This profile covers Innogenix, LLC. based in Amityville, New York, United States.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
1
NAI
2
Form 483s
1
Warning letters
0

First inspected May 14, 2018. Last inspected March 13, 2025.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Backup data not assured as exact and complete1 inspection
  • Computer control of master formula records1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
March 13, 2025NAIHuman Drugs · Bioresearch Monitoring1265322
November 15, 2024VAIHuman Drugs · Drug Quality Assurance1255158
May 14, 2018NAIHuman Drugs · Drug Quality Assurance1054753
FDA documents

Form 483s (1)

  • Form 483s · November 15, 2024

EIRs (1)

  • EIRs · May 14, 2018
People (4)
Manish R. Potti
Person
Sony Mathews
Person
Bijoy Panicker
Person
Emmanuel T. Donyina
Person
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Company Information

Name

Innogenix, LLC.

FEI Number

3013326213

Address

8200 New Horizons Blvd, Amityville, New York 11701, United States

Country

United States

ID: 0b066751-6110-474e-8c0e-cfa7821c4360

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