Sandoz GmbH
Form 483 issued December 17, 2021 · Kundl, Austria
- Inspection
- Dec 9 – Dec 17, 2021
- Investigators
- Wayne Seifert· Xianghong Jing
- Observations
- 5
- Pages
- 2
- FEI number
- 3002806523
In short: On December 17, 2021, FDA issued a Form 483 with 5 observations to Sandoz GmbH in Kundl, Tyrol (FEI 3002806523) after an inspection that ran Dec 9 – Dec 17, 2021. The investigators were Wayne Seifert and Xianghong Jing. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and materials account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
On 14 December 2021, I observed the (b)(4) drug substance filled into sterile bottles, with each…
- 02
Manufacturing utilities are deficient…
- 03
Within Building preparation Area there is no cleaning and/or sanitization of the raw material packaging for…
- 0421 CFR 207.17
: independent company supports raw material receipt foi rug substance manufacture, wi ity a GMP warehouse…
This inspection in context
Wayne Seifert
37 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
The firmSandoz 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sandoz GmbH?
FDA listed 5 observations on this Form 483, mostly about production, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Sandoz GmbH?
Wayne Seifert and Xianghong Jing are named on this Form 483, for the inspection of Dec 9 – Dec 17, 2021. Each investigator has a profile showing what they cite most.
When was Sandoz GmbH inspected by FDA?
The inspection ran Dec 9 – Dec 17, 2021, and the Form 483 is dated December 17, 2021.
How do I get the full Form 483 for Sandoz 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.