Novitium Pharma LLC
Form 483 issued July 8, 2021 · East Windsor, New Jersey
- Inspection
- Jun 30 – Jul 8, 2021
- Investigator
- Nicholas Violand
- Observations
- 1
- Pages
- 3
- FEI number
- 3012541241
In short: On July 8, 2021, FDA issued a Form 483 with 1 observation to Novitium Pharma LLC in East Windsor, New Jersey (FEI 3012541241) after an inspection that ran Jun 30 – Jul 8, 2021. The investigator was Nicholas Violand. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed that describe the in-process controls and tests to be conducted on…
This inspection in context
Nicholas Violand
17 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) 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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novitium Pharma LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Novitium Pharma LLC?
Nicholas Violand is named on this Form 483, for the inspection of Jun 30 – Jul 8, 2021. Each investigator has a profile showing what they cite most.
When was Novitium Pharma LLC inspected by FDA?
The inspection ran Jun 30 – Jul 8, 2021, and the Form 483 is dated July 8, 2021.
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.