Drug factory · FDA FEI 3003195501
Sanofi-Aventis Deutschland GmbH
Brüningstr. 50, Frankfurt am Main, Germany
Problems found, fixed voluntarily at FDA's last inspection, Mar 25, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2008: 2 with no problems, 7 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 25, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 14, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 3, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jun 26, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 5, 2013 | No problems found | Drug Quality Assurance | — |
| Jul 2, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 30, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 14, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 16, 2010 | Serious problems, FDA action | Drug Quality Assurance | — |
| Oct 31, 2008 | 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.
Mar 3, 2017 inspection
- 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. - 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. - Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. - Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.