Sandoz GmbH
Form 483 issued March 11, 2016 · Langkampfen, Austria
- Inspection
- Mar 7 – Mar 11, 2016
- Investigators
- Jose Lopez-Barragan· Peter Adams· Reyes Candau-Chacon
- Observations
- 2
- Pages
- 1
- FEI number
- 3004828473
In short: On March 11, 2016, FDA issued a Form 483 with 2 observations to Sandoz GmbH in Langkampfen, Tyrol (FEI 3004828473) after an inspection that ran Mar 7 – Mar 11, 2016. The investigators were Jose Lopez-Barragan, Peter Adams, Reyes Candau-Chacon and Zhong Li. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.111 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no demonstration of microbial control…
- 02
Hold times are not…
This inspection in context
Jose Lopez-Barragan
1 document · 2016
Cites 211.111 (time limitations on production) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sandoz GmbH?
FDA listed 2 observations on this Form 483, mostly about production. 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 Sandoz GmbH?
Jose Lopez-Barragan, Peter Adams, Reyes Candau-Chacon and Zhong Li are named on this Form 483, for the inspection of Mar 7 – Mar 11, 2016. Each investigator has a profile showing what they cite most.
When was Sandoz GmbH inspected by FDA?
The inspection ran Mar 7 – Mar 11, 2016, and the Form 483 is dated March 11, 2016.
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.