Company
South AfricaAspen SA Sterile Operations (Pty) Ltd., Port Elizabeth, South Africa – FDA Inspections
Inspection records and compliance data for Aspen SA Sterile Operations (Pty) Ltd. in Port Elizabeth. 6 FDA inspections on record (1 OAI), 3 Form 483s, last inspected July 14, 2026.
Company Profile
This profile covers Aspen SA Sterile Operations (Pty) Ltd. based in Port Elizabeth, South Africa.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected May 17, 2012. Last inspected July 14, 2026.
Most cited issue areas
- Scientifically sound laboratory controls4 inspections
- Absence of Written Procedures2 inspections
- Investigations of discrepancies, failures2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 14, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1326320 |
| September 17, 2024 | OAI | Human Drugs · Drug Quality Assurance | 1249416 |
| December 4, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1074310 |
| April 19, 2016 | VAI | Human Drugs · Drug Quality Assurance | 969055 |
| May 23, 2014 | NAI | Human Drugs · Drug Quality Assurance | 882533 |
| May 17, 2012 | NAI | Human Drugs · Drug Quality Assurance | 786162 |
FDA documents
People (4)
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Company Information
Name
Aspen SA Sterile Operations (Pty) Ltd.
FEI Number
3007490529
Address
8b Gibaud Road, Port Elizabeth, South Africa
Country
South Africa
ID: b4918ce4-3b81-4fb7-bd04-2e1110728456