Sandoz GmbH
Form 483 issued July 5, 2016 · Langkampfen, Austria
- Inspection
- Jun 27 – Jul 5, 2016
- Observations
- 3
- Pages
- 3
- FEI number
- 3004828473
In short: On July 5, 2016, FDA issued a Form 483 with 3 observations to Sandoz GmbH in Langkampfen, Tyrol (FEI 3004828473) after an inspection that ran Jun 27 – Jul 5, 2016. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written procedures are lacking which describe in sufficient detail…
- 03
Aseptic processing areas are deficient regarding the system…
This inspection in context
Questions about this 483
What did FDA find at Sandoz GmbH?
FDA listed 3 observations on this Form 483, mostly about quality system, materials and facilities & equipment. The opening words of each observation are shown on this page.
When was Sandoz GmbH inspected by FDA?
The inspection ran Jun 27 – Jul 5, 2016, and the Form 483 is dated July 5, 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.