Company
PolandSteriscience SP. Z O.O., Warsaw, Poland – FDA Inspections
Inspection records and compliance data for Steriscience SP. Z O.O. in Warsaw. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 28, 2023.
Company Profile
This profile covers Steriscience SP. Z O.O. based in Warsaw, Poland.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected September 13, 2012. Last inspected April 28, 2023.
Most cited issue areas
- Procedures for sterile drug products2 inspections
- Absence of Written Procedures1 inspection
- Changes to Procedures Not Reviewed, Approved1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 28, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1203774 |
| February 14, 2014 | OAI | Human Drugs · Drug Quality Assurance | 866277 |
| September 13, 2012 | VAI | Human Drugs · Drug Quality Assurance | 800716 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
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Mylan Laboratories Limited
Avara Liscate Pharmaceutical Services SPA
Gland Chemical Private Limited
Aspen SA Sterile Operations (Pty) Ltd.
Kaysersberg Pharmaceuticals SAS
ENDO Pharmaceuticals Solutions, Inc.
Fresenius Medical Care de Mexico, SA de CV
NextPharma OY
Company Information
Name
Steriscience SP. Z O.O.
FEI Number
3009685660
Address
Ul. Daniszewska 10, Warsaw, Poland
Country
Poland
ID: a2c32aee-8f5f-4bd3-8cc9-9fdcf970ebf4