Drug factory · FDA FEI 3002989591
Rovi Pharma Industrial Services SA
Calle Via Complutense, 140, Alcala de Henares, Spain
Problems found, fixed voluntarily at FDA's last inspection, Jan 17, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 1 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, packages it and labels it | Moderna US, Inc. | 80777-401 |
| Cx-055611 | Tests it, packages it and labels it | Moderna US, Inc. | 80777-114, 80777-115 |
| Rna-101-Bfl3 and Rna-101-Bfl5 and Rna-101-Bfl6 | Tests it, packages it and labels it | Moderna US, Inc. | 80777-500 |
| Sevelamer | Makes it, tests it, packages it and labels it | Genzyme Corporation, Sanofi-Aventis U.S. LLC | 58468-0130, 58468-0131, 58468-0132 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 17, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 14, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 4, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 2, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 23, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 14, 2018 inspection
- Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Feb 2, 2012 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch.
Apr 23, 2009 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation.
Registered with FDA for: analysis; label; manufacture; pack.