Nucrogene Inc
Form 483 issued October 9, 2024 · Branchburg, New Jersey
- Inspection
- Oct 3 – Oct 9, 2024
- Investigators
- Alisha B. Patel· Victoria Spivak
- Observations
- 4
- Pages
- 4
- FEI number
- 3016425516
In short: On October 9, 2024, FDA issued a Form 483 with 4 observations to Nucrogene Inc in Branchburg, New Jersey (FEI 3016425516) after an inspection that ran Oct 3 – Oct 9, 2024. The investigators were Alisha B. Patel and Victoria Spivak. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The written stability testing…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Alisha B. Patel
2 documents · 2024
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmNucrogene Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nucrogene Inc?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Nucrogene Inc?
Alisha B. Patel and Victoria Spivak are named on this Form 483, for the inspection of Oct 3 – Oct 9, 2024. Each investigator has a profile showing what they cite most.
When was Nucrogene Inc inspected by FDA?
The inspection ran Oct 3 – Oct 9, 2024, and the Form 483 is dated October 9, 2024.
How do I get the full Form 483 for Nucrogene Inc?
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.