Sandoz GmbH
Form 483 issued October 13, 2017 · Langkampfen, Austria
- Inspection
- Oct 9 – Oct 13, 2017
- Investigators
- Anjali Shukla· Scott R. Nichols· William Hallett
- Observations
- 1
- Pages
- 1
- FEI number
- 3004828473
In short: On October 13, 2017, FDA issued a Form 483 with 1 observation to Sandoz GmbH in Langkampfen, Tyrol (FEI 3004828473) after an inspection that ran Oct 9 – Oct 13, 2017. The investigators were Anjali Shukla, Scott R. Nichols, William Hallett and Zhong Li. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed during routine manufacturing operations of…
This inspection in context
Anjali Shukla
3 documents · 2017–2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Austria.
The firmSandoz GmbH history
All 5 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 1 observation on this Form 483, mostly about production. 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?
Anjali Shukla, Scott R. Nichols, William Hallett and Zhong Li are named on this Form 483, for the inspection of Oct 9 – Oct 13, 2017. Each investigator has a profile showing what they cite most.
When was Sandoz GmbH inspected by FDA?
The inspection ran Oct 9 – Oct 13, 2017, and the Form 483 is dated October 13, 2017.
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.