Novartis Consumer Health
Form 483 issued February 14, 2013 · Lincoln, Nebraska
- Inspection
- Jan 28 – Feb 14, 2013
- Investigators
- Eric M. Mueller· Joseph R. Lambert· Susanna E. Ford
- Observations
- 9
- Pages
- 13
- FEI number
- 1911445
In short: On February 14, 2013, FDA issued a Form 483 with 9 observations to Novartis Consumer Health in Lincoln, Nebraska (FEI 1911445) after an inspection that ran Jan 28 – Feb 14, 2013. The investigators were Eric M. Mueller, Joseph R. Lambert and Susanna E. Ford. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
5 of 8 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 02
Deviations from written production and process control procedures are…
- 03
Written records of investigations into unexplained discrepancies do not always include…
- 04
Written procedures are not followed for evaluations CQnducted at least annually to review rec.ords associated with…
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 9 observations on this Form 483, mostly about quality system, production and laboratory controls. 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, Joseph R. Lambert and Susanna E. Ford are named on this Form 483, for the inspection of Jan 28 – Feb 14, 2013. Each investigator has a profile showing what they cite most.
When was Novartis Consumer Health inspected by FDA?
The inspection ran Jan 28 – Feb 14, 2013, and the Form 483 is dated February 14, 2013.
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.