Novartis Consumer Health
Form 483 issued January 20, 2012 · Lincoln, Nebraska
- Inspection
- Dec 14, 2011 – Jan 20, 2012
- Investigators
- Adree N. Anderson· Eric M. Miller· Thuy T. Nguyen
- Observations
- 3
- Pages
- 23
- FEI number
- 1911445
In short: On January 20, 2012, FDA issued a Form 483 with 3 observations to Novartis Consumer Health in Lincoln, Nebraska (FEI 1911445) after an inspection that ran Dec 14, 2011 – Jan 20, 2012. The investigators were Adree N. Anderson, Eric M. Miller, Thuy T. Nguyen and Warren J. Lopicka. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not…
- 03
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
This inspection in context
Adree N. Anderson
4 documents · 2011–2012
Cites 118.10 (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Missouri.
The firmNovartis Consumer Health history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Consumer Health?
FDA listed 3 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Novartis Consumer Health?
Adree N. Anderson, Eric M. Miller, Thuy T. Nguyen and Warren J. Lopicka are named on this Form 483, for the inspection of Dec 14, 2011 – Jan 20, 2012. Each investigator has a profile showing what they cite most.
When was Novartis Consumer Health inspected by FDA?
The inspection ran Dec 14, 2011 – Jan 20, 2012, and the Form 483 is dated January 20, 2012.
How do I get the full Form 483 for Novartis Consumer Health?
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.