Aspen SA Sterile Operations PTY Ltd.
FDA inspection history in Korsten, South Africa, 2018 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Korsten, South Africa.
- 2024–25One Form 483 and one warning letter, at Korsten, South Africa.
- 2024The longest 483 on file: 12 observations over 22 pages at Korsten, South Africa.
Cited most
Across all Aspen SA Sterile Operations PTY observations on file
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.192Production record review2
The complete Aspen SA Sterile Operations PTY file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Korsten, South Africa
Two Form 483s · 2018 to 2024 · 22 observations
Latest: Form 483, Sep 17, 2024 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-24 | Warning letter Warning letter | — | — | $99 |
| 2024-09-17 | 483 Form 483 | Korsten, South Africa | 12 | $99 |
| 2018-12-04 | 483 Form 483 | Korsten, South Africa | 10 | $99 |
Investigators on these documents
Cheryl Clausen (1)Josh Renzo N. Ramilo (1)Justin A. Boyd (1)Michael R. Shanks (1)
FEI number 3007490529 · most recent document Feb 24, 2025
About Aspen SA Sterile Operations PTY Ltd.
How many FDA Form 483s has Aspen SA Sterile Operations PTY Ltd. received?
FDA Intel has 2 Form 483s on file for Aspen SA Sterile Operations PTY Ltd.; the most recent is dated Sep 17, 2024.
When was Aspen SA Sterile Operations PTY Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Aspen SA Sterile Operations PTY Ltd. is a Form 483 dated Sep 17, 2024, for the site in Korsten, South Africa.
What did FDA cite at Aspen SA Sterile Operations PTY Ltd.?
The regulations cited most in the observations on file for Aspen SA Sterile Operations PTY Ltd. are 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.160 (General requirements), 3 times.
Has Aspen SA Sterile Operations PTY Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Aspen SA Sterile Operations PTY Ltd.; the most recent is dated Feb 24, 2025.