ARNA Pharma Pty,, Ltd
Form 483 issued October 17, 2025 · Frenchs Forest, Australia
- Inspection
- Oct 13 – Oct 17, 2025
- Investigator
- Paranthaman Senthamaraikannan
- Observations
- 2
- Pages
- 4
- FEI number
- 3007428662
In short: On October 17, 2025, FDA issued a Form 483 with 2 observations to ARNA Pharma Pty,, Ltd in Frenchs Forest, Australia (FEI 3007428662) after an inspection that ran Oct 13 – Oct 17, 2025. The investigator was Paranthaman Senthamaraikannan. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Paranthaman Senthamaraikannan
6 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmARNA Pharma Pty,, Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ARNA Pharma Pty,, Ltd?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected ARNA Pharma Pty,, Ltd?
Paranthaman Senthamaraikannan is named on this Form 483, for the inspection of Oct 13 – Oct 17, 2025. Each investigator has a profile showing what they cite most.
When was ARNA Pharma Pty,, Ltd inspected by FDA?
The inspection ran Oct 13 – Oct 17, 2025, and the Form 483 is dated October 17, 2025.
How do I get the full Form 483 for ARNA Pharma Pty,, Ltd?
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