Sandoz GmbH
Form 483 issued May 6, 2011 · Broomfield, Colorado
- Inspection
- Apr 19 – May 6, 2011
- Investigators
- Erika V. Butler· Kimberley A. Hoefeo· Zachery L. Miller
- Observations
- 11
- Pages
- 9
- FEI number
- 1717759
In short: On May 6, 2011, FDA issued a Form 483 with 11 observations to Sandoz GmbH in Broomfield, Colorado (FEI 1717759) after an inspection that ran Apr 19 – May 6, 2011. The investigators were Erika V. Butler, Kimberley A. Hoefeo and Zachery L. Miller. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.160(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 03
The quality control unit lacks authority to fully investigate…
- 04
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
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 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sandoz GmbH?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sandoz GmbH?
Erika V. Butler, Kimberley A. Hoefeo and Zachery L. Miller are named on this Form 483, for the inspection of Apr 19 – May 6, 2011. Each investigator has a profile showing what they cite most.
When was Sandoz GmbH inspected by FDA?
The inspection ran Apr 19 – May 6, 2011, and the Form 483 is dated May 6, 2011.
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.