Leo Pharma Gmbh
Overview
Leo Pharma Gmbh is a pharmaceutical company headquartered in Neu-isenburg, Germany, with 201-500 employees.
Active pharmaceutical ingredients supplied
Substances Leo Pharma Gmbh is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
FDA compliance signals
5 FDA enforcement records linked to this company.
- recall — Class II2026-03-04
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
- recall — Class II2017-03-15
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
- recall — Class III2017-02-22
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
- 4832014-09-19
Failure to develop written procedures
- 4832014-09-19
Late submission of 15-day report
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