Drug factory · FDA FEI 3016688535

Rovi Pharma Industrial Services S.a.

Paseo de Europa, 50, San Sebastián de los Reyes, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 3, 2021.

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

1 drug inspection on record since 2021: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Cx-055610Makes it and tests it Moderna US, Inc. 80777-401
Cx-055611Makes it Moderna US, Inc. 80777-114, 80777-115
Rna-101-Bfl3 and Rna-101-Bfl5 and Rna-101-Bfl6Makes it Moderna US, Inc. 80777-500

FDA inspection history

EndedResultProgramProblems noted
Jun 3, 2021Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; manufacture; pack.