Sandoz GmbH
Form 483 issued February 20, 2018 · Langkampfen, Austria
- Inspection
- Feb 14 – Feb 20, 2018
- Investigators
- Deborah Schmiel· Laura Fontan· Marjorie A. Shapiro
- Observations
- 4
- Pages
- 1
- FEI number
- 3004828473
In short: On February 20, 2018, FDA issued a Form 483 with 4 observations to Sandoz GmbH in Langkampfen, Tyrol (FEI 3004828473) after an inspection that ran Feb 14 – Feb 20, 2018. The investigators were Deborah Schmiel, Laura Fontan, Marjorie A. Shapiro and Michael R. Shanks. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
3 of 4 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Microbial hold times for”)…
- 02
Appropriate controls are lacking for i testing machines to assure that only authorized personnel institute…
- 03
Standard operating procedures are…
- 04
The method for determination of material conformance to written…
This inspection in context
Deborah Schmiel
5 documents · 2016–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in South Korea.
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 211.111
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 production 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?
Deborah Schmiel, Laura Fontan, Marjorie A. Shapiro and Michael R. Shanks are named on this Form 483, for the inspection of Feb 14 – Feb 20, 2018. Each investigator has a profile showing what they cite most.
When was Sandoz GmbH inspected by FDA?
The inspection ran Feb 14 – Feb 20, 2018, and the Form 483 is dated February 20, 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.