Company
IndiaSteriscience Specialties Private Limited, Bengaluru, India – FDA Inspections
Inspection records and compliance data for Steriscience Specialties Private Limited in Bengaluru. 8 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 28, 2024.
Company Profile
This profile covers Steriscience Specialties Private Limited based in Bengaluru, India.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 6
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 17, 2009. Last inspected March 28, 2024.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Procedures for sterile drug products2 inspections
- Representative Samples2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 28, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1234275 |
| December 20, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1114642 |
| March 13, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1044193 |
| March 16, 2016 | VAI | Human Drugs · Drug Quality Assurance | 963420 |
| August 8, 2014 | OAI | Human Drugs · Drug Quality Assurance | 890880 |
| August 12, 2013 | VAI | Human Drugs · Drug Quality Assurance | 847764 |
| September 29, 2011 | VAI | Human Drugs · Drug Quality Assurance | 750682 |
| March 17, 2009 | NAI | Human Drugs · Drug Quality Assurance | 574559 |
FDA documents
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Kaysersberg Pharmaceuticals SAS
ENDO Pharmaceuticals Solutions, Inc.
Mylan Laboratories Limited
Ningbo Shuangcheng Pharmaceutical Co., Ltd
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)
Baxter Pharmaceuticals India Pvt Ltd
Gland Chemical Private Limited
Avara Liscate Pharmaceutical Services SPA
Aspen SA Sterile Operations (Pty) Ltd.
Lyocontract GmbH
Company Information
Name
Steriscience Specialties Private Limited
FEI Number
3003813519
Address
Sterile Product Division, Opp Iim, Bannerghatta Road, Bengaluru, India
Country
India
ID: f2814c8b-daff-42a4-abe2-59947a5bda3d