Ascent Pharmaceuticals Inc
Form 483 issued September 15, 2022 · Central Islip, New York
- Inspection
- Sep 12 – Sep 15, 2022
- Investigator
- Tyanna N. Hadley
- Observations
- 1
- Pages
- 2
- FEI number
- 3009518416
In short: On September 15, 2022, FDA issued a Form 483 with 1 observation to Ascent Pharmaceuticals Inc in Central Islip, New York (FEI 3009518416) after an inspection that ran Sep 12 – Sep 15, 2022. The investigator was Tyanna N. Hadley.
What FDA observed
Preview: the opening words of each observation- 01FDCA 505-1(f)(4)
An application holder did not maintain a Support / Call Center or a REMS Program website…
This inspection in context
Tyanna N. Hadley
3 documents · 2022–2024
Cites 314.80(b) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in New Jersey.
The firmAscent Pharmaceuticals Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sMore form 483s
Browse other documents of this type.
Questions about this 483
What did FDA find at Ascent Pharmaceuticals Inc?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected Ascent Pharmaceuticals Inc?
Tyanna N. Hadley is named on this Form 483, for the inspection of Sep 12 – Sep 15, 2022. Each investigator has a profile showing what they cite most.
When was Ascent Pharmaceuticals Inc inspected by FDA?
The inspection ran Sep 12 – Sep 15, 2022, and the Form 483 is dated September 15, 2022.
How do I get the full Form 483 for Ascent Pharmaceuticals 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.