Sandoz Canada, Inc
Form 483 issued August 4, 2011 · Boucherville, Canada
- Inspection
- Jul 26 – Aug 4, 2011
- Investigator
- Sharon K. Thoma
- Observations
- 1
- Pages
- 1
- FEI number
- 3000280957
In short: On August 4, 2011, FDA issued a Form 483 with 1 observation to Sandoz Canada, Inc in Boucherville, Quebec JB K (FEI 3000280957) after an inspection that ran Jul 26 – Aug 4, 2011. The investigator was Sharon K. Thoma. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Sharon K. Thoma
9 documents · 2009–2016
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmSandoz Canada, Inc 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 Canada, Inc?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sandoz Canada, Inc?
Sharon K. Thoma is named on this Form 483, for the inspection of Jul 26 – Aug 4, 2011. Each investigator has a profile showing what they cite most.
When was Sandoz Canada, Inc inspected by FDA?
The inspection ran Jul 26 – Aug 4, 2011, and the Form 483 is dated August 4, 2011.
How do I get the full Form 483 for Sandoz Canada, Inc?
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.