Drug factory · FDA FEI 3002807447
Merck Serono Sa
Zone Industrielle de l'Ouriettaz, Aubonne, Switzerland
No problems found at FDA's last inspection, May 2, 2023.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2009: 1 with no problems, 6 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Adalimumab and Isopropyl Alcohol | Makes it, packages it and labels it | Fresenius Kabi USA, LLC | 65219-558 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 2, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 18, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 6, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 12, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 16, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 16, 2011 | Serious problems, FDA action | Drug Quality Assurance | — |
| Dec 9, 2009 | Problems found, fixed voluntarily | 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.
May 9, 2018 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process. - Complaints reviewed by Quality Control Unit 21 CFR 211.198(a)
Written procedures describing the handling of complaints do not include provisions for a determination as to the need for an investigation of any unexplained discrepancy and explaining the reasons for the failure of the batch or any of its components to meet specifications.
Nov 6, 2015 inspection
- Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.