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Steril-Gene Life Sciences Private Ltd, Puducherry, India – FDA Inspections

Inspection records and compliance data for Steril-Gene Life Sciences Private Ltd in Puducherry. 4 FDA inspections on record, 2 Form 483s, last inspected August 12, 2026.

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Company Profile

This profile covers Steril-Gene Life Sciences Private Ltd based in Puducherry, India.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
2
NAI
0
Unclassified
2
Form 483s
2
Warning letters
0

First inspected December 10, 2019. Last inspected August 12, 2026.

Most cited issue areas

  • SOPs not followed / documented2 inspections
  • Absence of Written Procedures1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
August 12, 2026Not classifiedAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance1330818
March 12, 2025Not classifiedHuman Drugs1264873
November 25, 2022VAIHuman Drugs · Drug Quality Assurance1194139
December 10, 2019VAIAnimal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives1114641
FDA documents

Form 483s (4)

  • Form 483s · August 12, 2026
  • Form 483s · March 3, 2025
  • Form 483s · November 17, 2022
  • Form 483s · December 10, 2019
Other regulators (1)
  • UK MHRA · 1 inspection · last February 5, 2024
People (3)
Jose F. Velez
Person
Dennis Cantellops Paite
Person
Lisa L. Flores
Person
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Company Information

Name

Steril-Gene Life Sciences Private Ltd

FEI Number

3014319211

Address

No.45 Main Road, Mangalam Village, Villianur Commune, Puducherry, India

Country

India

ID: 0885ef5e-2fd7-42c0-927d-7cf3c2410eec

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