Drug factory · FDA FEI 3007512884
ROVI Pharma Industrial Services S.A.
Julián Camarillo, 35, Madrid, Spain
Problems found, fixed voluntarily at FDA's last inspection, Mar 14, 2024.
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 2012: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cx-055610 | Tests it | Moderna US, Inc. | 80777-401 |
| Cx-055611 | Makes it and tests it | Moderna US, Inc. | 80777-114, 80777-115 |
| Rna-101-Bfl3 and Rna-101-Bfl5 and Rna-101-Bfl6 | Tests it | Moderna US, Inc. | 80777-500 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 14, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 5, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 25, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Mar 27, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jul 3, 2012 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 22, 2016 inspection
- 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. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
Mar 27, 2014 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Written sanitation procedures lacking 21 CFR 211.56(b)
There is a lack of written procedures providing cleaning schedules and describing in sufficient detail the methods, equipment and materials to be used for sanitation. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.