Novartis Consumer Health
Form 483 issued September 30, 2021 · Lincoln, Nebraska
- Inspection
- Sep 20 – Sep 30, 2021
- Investigators
- Jacob G. Lutz· Lisa L. Flores· Sandra A. Boyd
- Observations
- 5
- Pages
- 6
- FEI number
- 1911445
In short: On September 30, 2021, FDA issued a Form 483 with 5 observations to Novartis Consumer Health in Lincoln, Nebraska (FEI 1911445) after an inspection that ran Sep 20 – Sep 30, 2021. The investigators were Jacob G. Lutz, Lisa L. Flores and Sandra A. Boyd. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
This inspection in context
Jacob G. Lutz
14 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Novartis Consumer Health?
Jacob G. Lutz, Lisa L. Flores and Sandra A. Boyd are named on this Form 483, for the inspection of Sep 20 – Sep 30, 2021. Each investigator has a profile showing what they cite most.
When was Novartis Consumer Health inspected by FDA?
The inspection ran Sep 20 – Sep 30, 2021, and the Form 483 is dated September 30, 2021.
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.