Portal 724 LLC
Form 483 issued September 21, 2023 · Secaucus, New Jersey
- Inspection
- Sep 12 – Sep 21, 2023
- Investigator
- Colin E. Tack
- Observations
- 7
- Pages
- 7
- FEI number
- 3010729874
In short: On September 21, 2023, FDA issued a Form 483 with 7 observations to Portal 724 LLC in Secaucus, New Jersey (FEI 3010729874) after an inspection that ran Sep 12 – Sep 21, 2023. The investigator was Colin E. Tack. Most observations concern cAPA and design controls.
At a glance
CAPA and design controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 02
Written MDR procedures have not been…
- 03
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 04
Procediues for design control…
This inspection in context
Colin E. Tack
8 documents · 2019–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmPortal 724 LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Portal 724 LLC?
FDA listed 7 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Portal 724 LLC?
Colin E. Tack is named on this Form 483, for the inspection of Sep 12 – Sep 21, 2023. Each investigator has a profile showing what they cite most.
When was Portal 724 LLC inspected by FDA?
The inspection ran Sep 12 – Sep 21, 2023, and the Form 483 is dated September 21, 2023.
How do I get the full Form 483 for Portal 724 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.