Drug factory · FDA FEI 3007428662

Arna Pharma Pty Ltd

20 Rodborough Rd, Frenchs Forest, Australia

Problems found, fixed voluntarily at FDA's last inspection, Oct 17, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

4 drug inspections on record since 2009: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Mannitol	Makes it, tests it and packages it	Methapharm, Inc.	67850-552

Ended	Result	Program	Problems noted
Oct 17, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	3
May 17, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	1
Sep 21, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 16, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Registered with FDA for: analysis; manufacture; pack.