Sandoz GmbH
Form 483 issued April 16, 2019 · Broomfield, Colorado
- Inspection
- Apr 8 – Apr 16, 2019
- Investigator
- Erika V. Butler
- Observations
- 3
- Pages
- 5
- FEI number
- 1717759
In short: On April 16, 2019, FDA issued a Form 483 with 3 observations to Sandoz GmbH in Broomfield, Colorado (FEI 1717759) after an inspection that ran Apr 8 – Apr 16, 2019. The investigator was Erika V. Butler. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls 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
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 3 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sandoz GmbH?
Erika V. Butler is named on this Form 483, for the inspection of Apr 8 – Apr 16, 2019. Each investigator has a profile showing what they cite most.
When was Sandoz GmbH inspected by FDA?
The inspection ran Apr 8 – Apr 16, 2019, and the Form 483 is dated April 16, 2019.
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.