Ascendis Pharma LLC
Form 483 issued March 6, 2026 · Palo Alto, California
- Inspection
- Mar 3 – Mar 6, 2026
- Investigators
- Kristin M. Abaonza· Scott N. Lim
- Observations
- 2
- Pages
- 3
- FEI number
- 3022069968
In short: On March 6, 2026, FDA issued a Form 483 with 2 observations to Ascendis Pharma LLC in Palo Alto, California (FEI 3022069968) after an inspection that ran Mar 3 – Mar 6, 2026. The investigators were Kristin M. Abaonza and Scott N. Lim. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
At a glance
Observations span 1 system, led by biologics cgmp.
Most cited: 21 CFR 314.80(c)(1)(i) (1×) · 600.80(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Kristin M. Abaonza
12 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmAscendis Pharma LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.80(c)(1)(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ascendis Pharma LLC?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Ascendis Pharma LLC?
Kristin M. Abaonza and Scott N. Lim are named on this Form 483, for the inspection of Mar 3 – Mar 6, 2026. Each investigator has a profile showing what they cite most.
When was Ascendis Pharma LLC inspected by FDA?
The inspection ran Mar 3 – Mar 6, 2026, and the Form 483 is dated March 6, 2026.
How do I get the full Form 483 for Ascendis Pharma 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.