Company
IrelandSK Biotek Ireland Ltd., Swords, Ireland – FDA Inspections
Inspection records and compliance data for SK Biotek Ireland Ltd. in Swords. 6 FDA inspections on record, 1 Form 483, last inspected May 13, 2022.
Company Profile
This profile covers SK Biotek Ireland Ltd. based in Swords, Ireland.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 12, 2011. Last inspected May 13, 2022.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 13, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1228150 |
| April 5, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1123642 |
| November 3, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1035255 |
| February 25, 2016 | VAI | Human Drugs · Drug Quality Assurance | 963209 |
| September 20, 2013 | NAI | Human Drugs · Drug Quality Assurance | 848526 |
| May 12, 2011 | NAI | Human Drugs · Drug Quality Assurance | 725194 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Sterling Pharma Ringaskiddy Limited
Bristol-Myers Squibb Cruiserath Biologics
Thermo Fisher Scientific Cork Limited
Sigma-Aldrich Ireland Ltd.
Astellas Ireland Co., Ltd.
Ipsen Manufacturing Ireland Ltd.
Upjohn Manufacturing Ireland Unlimited Company
Janssen Pharmaceutical Sciences Unlimited Company
Maithri Drugs Private Limited
Polypeptide Laboratories France
Company Information
Name
SK Biotek Ireland Ltd.
FEI Number
3002806583
Address
Watery Lane, Swords, Ireland
Country
Ireland
ID: 1d9664f1-9235-4856-b8f8-5a123618b3cc