Aspen SA Sterile Operations PTY Ltd.
Form 483 issued September 17, 2024 · Korsten, South Africa
- Inspection
- Sep 9 – Sep 17, 2024
- Investigators
- Josh Renzo N. Ramilo· Justin A. Boyd
- Observations
- 12
- Pages
- 22
- FEI number
- 3007490529
In short: On September 17, 2024, FDA issued a Form 483 with 12 observations to Aspen SA Sterile Operations PTY Ltd. in Korsten, EASTERN CAPE (FEI 3007490529) after an inspection that ran Sep 9 – Sep 17, 2024. The investigators were Josh Renzo N. Ramilo and Justin A. Boyd. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 9 of 12 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Josh Renzo N. Ramilo
6 documents · 2023–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmAspen SA Sterile Operations PTY Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aspen SA Sterile Operations PTY Ltd.?
FDA listed 12 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Aspen SA Sterile Operations PTY Ltd.?
Josh Renzo N. Ramilo and Justin A. Boyd are named on this Form 483, for the inspection of Sep 9 – Sep 17, 2024. Each investigator has a profile showing what they cite most.
When was Aspen SA Sterile Operations PTY Ltd. inspected by FDA?
The inspection ran Sep 9 – Sep 17, 2024, and the Form 483 is dated September 17, 2024.
How do I get the full Form 483 for Aspen SA Sterile Operations PTY Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.