Invaderm Corporation
Form 483 issued October 17, 2024 · Somerset, New Jersey
- Inspection
- Oct 15 – Oct 17, 2024
- Investigator
- David A. Oluwo
- Observations
- 2
- Pages
- 3
- FEI number
- 3010165760
In short: On October 17, 2024, FDA issued a Form 483 with 2 observations to Invaderm Corporation in Somerset, New Jersey (FEI 3010165760) after an inspection that ran Oct 15 – Oct 17, 2024. The investigator was David A. Oluwo. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Materials and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.84 (1×) · 211.180 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 02
Written procedures are not established and followed for evaluations done at least (B) (4) and including…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmInvaderm Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Invaderm Corporation?
FDA listed 2 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Invaderm Corporation?
David A. Oluwo is named on this Form 483, for the inspection of Oct 15 – Oct 17, 2024. Each investigator has a profile showing what they cite most.
When was Invaderm Corporation inspected by FDA?
The inspection ran Oct 15 – Oct 17, 2024, and the Form 483 is dated October 17, 2024.
How do I get the full Form 483 for Invaderm Corporation?
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.