Drug factory · FDA FEI 3002807468

LEO Laboratories Ltd.

285 Cashel Road, Crumlin, Dublin, Ireland

Problems found, fixed voluntarily at FDA's last inspection, Jan 30, 2026.

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

6 drug inspections on record since 2008: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Betamethasone and Calcipotriene	Makes it, tests it, packages it and labels it	LEO Pharma Inc., Prasco Laboratories	50222-302, 50222-501, 66993-938
Calcipotriene	Makes it, tests it, packages it and labels it	Prasco Laboratories	66993-877, 66993-878
Tacrolimus	Makes it, tests it, packages it and labels it	Padagis Israel Pharmaceuticals Ltd	45802-390, 45802-700

Ended	Result	Program	Problems noted
Jan 30, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 24, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	2
Nov 3, 2017	No problems found	Drug Quality Assurance	—
Mar 14, 2014	No problems found	Drug Quality Assurance	—
Sep 9, 2011	No problems found	Drug Quality Assurance	—
Dec 8, 2008	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.

Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over air pressure and dust is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Plumbing System Defects 21 CFR 211.48(a)
The plumbing system contains defects that could contribute to the contamination of drug products.

Registered with FDA for: analysis; label; manufacture; pack.