Ingenus Pharmaceuticals NJ LLC
Form 483 issued December 14, 2017 · Fairfield, New Jersey
- Inspection
- Dec 11 – Dec 14, 2017
- Investigator
- Junho Pak
- Observations
- 3
- Pages
- 3
- FEI number
- 2246963
In short: On December 14, 2017, FDA issued a Form 483 with 3 observations to Ingenus Pharmaceuticals NJ LLC in Fairfield, New Jersey (FEI 2246963) after an inspection that ran Dec 11 – Dec 14, 2017. The investigator was Junho Pak. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written specifications are…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 03
Test devices are deficient in that instruments and apparatus not meeting…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmIngenus Pharmaceuticals NJ LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ingenus Pharmaceuticals NJ LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Ingenus Pharmaceuticals NJ LLC?
Junho Pak is named on this Form 483, for the inspection of Dec 11 – Dec 14, 2017. Each investigator has a profile showing what they cite most.
When was Ingenus Pharmaceuticals NJ LLC inspected by FDA?
The inspection ran Dec 11 – Dec 14, 2017, and the Form 483 is dated December 14, 2017.
How do I get the full Form 483 for Ingenus Pharmaceuticals NJ 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.