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Steriscience Specialties Private Limited, Bengaluru, India – FDA Inspections

Inspection records and compliance data for Steriscience Specialties Private Limited in Bengaluru. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected November 22, 2024.

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Company Profile

This profile covers Steriscience Specialties Private Limited based in Bengaluru, India.

FDA Inspection History

FDA inspections
4
OAI
1
VAI
2
NAI
0
Unclassified
1
Form 483s
2
Warning letters
0

First inspected February 3, 2011. Last inspected November 22, 2024.

Most cited issue areas

  • Changes to Procedures Not Reviewed, Approved1 inspection
  • Computer control of master formula records1 inspection
  • Equipment Design, Size and Location1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
November 22, 2024Not classifiedHuman Drugs · Drug Quality Assurance1256494
February 14, 2019VAIHuman Drugs · Drug Quality Assurance1079813
September 1, 2015OAIHuman Drugs · Drug Quality Assurance940034
February 3, 2011VAIHuman Drugs · Drug Quality Assurance712230
FDA documents

Form 483s (4)

  • Form 483s · November 22, 2024
  • Form 483s · February 14, 2019
  • Form 483s · September 1, 2015
  • Form 483s · August 19, 2013
People (5)
Regina T. Brown
Person
Tajah L. Blackburn
Person
Felix Maldonado
Person
Nicholas A. Violand
Person
Bijoy Panicker
Person
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Company Information

Name

Steriscience Specialties Private Limited

FEI Number

3005652193

Address

Beta Lactam Division, Doresanipalya, 152/6 & 154/16, Bannerghatta Road, Bengaluru, India

Country

India

ID: 975a3188-8291-4516-ab80-57e5e3fed081

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