Novartis Consumer Health
Form 483 issued July 8, 2011 · Lincoln, Nebraska
- Inspection
- Jun 13 – Jul 8, 2011
- Investigators
- Eric M. Mueller· Joseph R. Lambert
- Observations
- 13
- Pages
- 13
- FEI number
- 1911445
In short: On July 8, 2011, FDA issued a Form 483 with 13 observations to Novartis Consumer Health in Lincoln, Nebraska (FEI 1911445) after an inspection that ran Jun 13 – Jul 8, 2011. The investigators were Eric M. Mueller and Joseph R. Lambert. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
10 of 13 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (3×) · 211.198(a) (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 03
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 04
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Eric M. Mueller
6 documents · 2009–2015
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Nebraska.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Consumer Health?
FDA listed 13 observations on this Form 483, mostly about quality system and production. 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 Novartis Consumer Health?
Eric M. Mueller and Joseph R. Lambert are named on this Form 483, for the inspection of Jun 13 – Jul 8, 2011. Each investigator has a profile showing what they cite most.
When was Novartis Consumer Health inspected by FDA?
The inspection ran Jun 13 – Jul 8, 2011, and the Form 483 is dated July 8, 2011.
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.