Company
South AfricaAspen SA OSD Operations Pty Ltd., Korsten, South Africa – FDA Inspections
Inspection records and compliance data for Aspen SA OSD Operations Pty Ltd. in Korsten. 4 FDA inspections on record, 1 Form 483, last inspected December 08, 2017.
Company Profile
This profile covers Aspen SA OSD Operations Pty Ltd. based in Korsten, South Africa.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 12, 2010. Last inspected December 8, 2017.
Most cited issue areas
- Reprocessing procedures not written or followed1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1034492 |
| June 24, 2016 | VAI | Human Drugs · Drug Quality Assurance | 981576 |
| May 23, 2014 | VAI | Human Drugs · Drug Quality Assurance | 883568 |
| February 12, 2010 | NAI | Human Drugs · Drug Quality Assurance | 646901 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Aspen SA OSD Operations Pty Ltd.
FEI Number
3003692704
Address
Cnr. Fairclough Road, Gibaud Rd., Korsten, South Africa
Country
South Africa
ID: a8378037-47f3-4aa5-bcf5-3a36afe36542