Aculife Healthcare: saline bags and timolol drops stall in the EU
Maltese inspectors found a critical cleaning-validation gap and eight major findings at this Indian sterile plant. Its pending EU filings for saline bags and timolol eye drops are caught.
Is your product on this list?
Products at risk. Who's in.
In the NCRnamed in the EU non-compliance report
| MOLECULE | FORM | SOLD IN THE EU BY | LINK TO SITE | RISK | WHO'S IN | Action |
|---|---|---|---|---|---|---|
| Sodium chloride 0.9% | IV infusion, nPVC bag | EU filing pending (CZ, DE, ES, PT) | IN THE NCR | FILING AT RISK | 12 FDF | See who's in |
| Timolol 5 mg/mL | Eye drops | EU filing pending (ES, MT, PT, HU) | IN THE NCR | FILING AT RISK | 20 API (7 CEP) · 132 FDF | See who's in |
"Who's in" counts manufacturers of the same molecule in the API-FDF database; the number in brackets holds a CEP. Names and contacts are inside.
What EU regulators found
- Critical: inadequate cleaning validation.
- Sterilised product passed through an area where unsterilised bags waited for the autoclave.
- Container closure integrity testing was inadequate, a problem the site had known about for a long time.
- Further major findings: identification labels in production, visual inspection, process validation, complaints and aseptic process simulations.
Timeline
How it got here
14 JUL 2026
Inspection ends
24 AUG 2026
Malta issues the statement of non-compliance: no EU supply, no new approvals naming the site