Sandoz, Inc.
Form 483 issued August 13, 2015 · Wilson, North Carolina
- Inspection
- Aug 4 – Aug 13, 2015
- Investigator
- Seneca Toms
- Observations
- 2
- Pages
- 1
- FEI number
- 3000210731
In short: On August 13, 2015, FDA issued a Form 483 with 2 observations to Sandoz, Inc. in Wilson, North Carolina (FEI 3000210731) after an inspection that ran Aug 4 – Aug 13, 2015. The investigator was Seneca Toms. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.58 (1×) · 211.42(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained…
- 02
The separate or defined areas and control systems necessary to prevent contamination…
This inspection in context
Seneca Toms
17 documents · 2013–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmSandoz, 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 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sandoz, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Sandoz, Inc.?
Seneca Toms is named on this Form 483, for the inspection of Aug 4 – Aug 13, 2015. Each investigator has a profile showing what they cite most.
When was Sandoz, Inc. inspected by FDA?
The inspection ran Aug 4 – Aug 13, 2015, and the Form 483 is dated August 13, 2015.
How do I get the full Form 483 for Sandoz, 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.