Sanofi-Aventis Deutschland GmbH
Form 483 issued January 16, 2025 · Frankfurt am Main, Germany
- Inspection
- Jan 8 – Jan 16, 2025
- Investigators
- Madushini Dharmasena· Michal Levine Millrod· Rachel Lokanga
- Observations
- 4
- Pages
- 2
- FEI number
- 3003195501
In short: On January 16, 2025, FDA issued a Form 483 with 4 observations to Sanofi-Aventis Deutschland GmbH in Frankfurt am Main, Germany (FEI 3003195501) after an inspection that ran Jan 8 – Jan 16, 2025. The investigators were Madushini Dharmasena, Michal Levine Millrod and Rachel Lokanga. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination fre oles drug products purporting to be sterile are…
- 02
manufacturing area is not under control…
- 03
01 storage, and process. Although Step does not assure product quality for an generation process is…
- 04
There is a lack of assurance that the cleaning procedures used for…
This inspection in context
Madushini Dharmasena
13 documents · 2019–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmSanofi-Aventis Deutschland GmbH history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi-Aventis Deutschland GmbH?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sanofi-Aventis Deutschland GmbH?
Madushini Dharmasena, Michal Levine Millrod and Rachel Lokanga are named on this Form 483, for the inspection of Jan 8 – Jan 16, 2025. Each investigator has a profile showing what they cite most.
When was Sanofi-Aventis Deutschland GmbH inspected by FDA?
The inspection ran Jan 8 – Jan 16, 2025, and the Form 483 is dated January 16, 2025.
How do I get the full Form 483 for Sanofi-Aventis Deutschland GmbH?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.