Novitium Pharma LLC
Form 483 issued February 4, 2019 · East Windsor, New Jersey
- Inspection
- Feb 4, 2019
- Investigator
- Frederick Razzaghi
- Observations
- 3
- Pages
- 2
- FEI number
- 3012541241
In short: On February 4, 2019, FDA issued a Form 483 with 3 observations to Novitium Pharma LLC in East Windsor, New Jersey (FEI 3012541241) after an inspection that ran Feb 4, 2019. The investigator was Frederick Razzaghi. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Quality system Changes to approved applications are not adequately assessed and controlled by the quality unit…
- 02
Laboratory system Laboratory records do not include complete records of testing and standardization…
- 03
Quality system The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmNovitium Pharma LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novitium Pharma LLC?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Novitium Pharma LLC?
Frederick Razzaghi is named on this Form 483, for the inspection of Feb 4, 2019. Each investigator has a profile showing what they cite most.
When was Novitium Pharma LLC inspected by FDA?
The inspection ran Feb 4, 2019, and the Form 483 is dated February 4, 2019.
How do I get the full Form 483 for Novitium Pharma LLC?
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.