Sandoz GmbH
Form 483 issued September 18, 2018 · Kundl, Austria
- Inspection
- Sep 10 – Sep 18, 2018
- Investigators
- Margaret M. Annes· Susan T. Hadman
- Observations
- 4
- Pages
- 3
- FEI number
- 3002806523
In short: On September 18, 2018, FDA issued a Form 483 with 4 observations to Sandoz GmbH in Kundl, Tyrol (FEI 3002806523) after an inspection that ran Sep 10 – Sep 18, 2018. The investigators were Margaret M. Annes and Susan T. Hadman. Most observations concern quality system and laboratory controls.
At a glance
Observations span 3 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sandoz GmbH?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Sandoz GmbH?
Margaret M. Annes and Susan T. Hadman are named on this Form 483, for the inspection of Sep 10 – Sep 18, 2018. Each investigator has a profile showing what they cite most.
When was Sandoz GmbH inspected by FDA?
The inspection ran Sep 10 – Sep 18, 2018, and the Form 483 is dated September 18, 2018.
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.