Has Ascendis Pharma LLC had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Ascendis Pharma LLC so far. Argus ingests new FDA records daily.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3022069968.

Is a Form 483 the same as a Warning Letter?

No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

Where can I read the full Form 483?

The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

Form 483 Record: Ascendis Pharma LLC, March 6, 2026

Key facts

Firm	Ascendis Pharma LLC
FEI / inspection ID	3022069968
Inspection end date	March 6, 2026
Citation count	2

The short version: FDA inspected Ascendis Pharma LLC in California, USA and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2026-03-06. FDA's inspection record does not classify Ascendis Pharma LLC's facility type further. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record. A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

Citations explained

Observation 1 — Not all adverse drug experiences that are both serious and unexpected have been reported

Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of iniƟal receipt of the informaƟon. Specifically, On 13 Jun 2025, the firm received a spontaneous consumer report (case 2025US009908) describing hospitalizaƟon following Yorvipath use. The firm's own triage, completed 16 Jun 2025, idenƟfied the case as serious (hospitalizaƟon), unexpected, and expedited. The firm subsequently classified case 2025US009908 as non-valid on the basis that no paƟent idenƟfier was available. The firm's own case narraƟve documented a single paƟent's sequenƟal 12-day clinical course including laboratory values, emergency care at a hospital, and inpaƟent treatment — meeƟng the threshold for an idenƟfiable paƟent. No 15-day expedited report was submiƩed to FDA for case 2025US009908. Furthermore, internal firm correspondence dated 18 Jun 2025 confirms that the firm applied the same non-valid classificaƟon collecƟvely to three addiƟonal adverse event reports from the same social media source, each previously idenƟfied by the firm's own operaƟons team as individual paƟent adverse event reports, on the basis of absent reporter email address an

Observation 2 — There are no wriƩen procedures for the surveillance, receipt, evaluaƟon and reporƟng of

There are no wriƩen procedures for the surveillance, receipt, evaluaƟon and reporƟng of post-markeƟng adverse experiences to FDA. Specifically, No wriƩen procedures to ensure systemaƟc surveillance, receipt, and reporƟng of post-markeƟng adverse experiences idenƟfied through social media monitoring to FDA for SKYTROFA and YORVIPATH. PAGE 1 of 2 PAGES Scott N Lim Consumer Safety Officer Signed By: 2002619245 Date Signed: 03-06-2026 14:48:34 -- 1 of 3 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION 1201 Harbor Bay Parkway Alameda, CA 94502-7070 (510)337-6700 Fax:(510)337-6702 3/3/2026-3/6/2026 FEI NUMBER 3022069968 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED Mandeep Singh, Global Patient Safety FIRM NAME STREET ADDRESS Ascendis Pharma LLC 1000 Page Mill Rd CITY, STATE, ZIP CODE, COUNTRY TYPE ESTABLISHMENT INSPECTED Palo Alto, CA 94304-1019 PADE EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE OF THIS PAGE Scott N Lim, Consumer Safety Officer Kristin M Abaonza, Investigator ʖ X 3/6/2026 FORM FDA 483 (09/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS ʖ X . . . . . . PAGE 2 of 2 PAGES Scott N Li

What a Form 483 means

A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

Ascendis Pharma LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Ascendis Pharma LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

Has Ascendis Pharma LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Ascendis Pharma LLC so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3022069968.
Is a Form 483 the same as a Warning Letter?: No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
Where can I read the full Form 483?: The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

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Full FDA history for Ascendis Pharma LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Form 483 Record: Ascendis Pharma LLC, March 6, 2026 — 2 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/ascendis-pharma-3022069968-2026-03-06

MLA

"Form 483 Record: Ascendis Pharma LLC, March 6, 2026 — 2 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/ascendis-pharma-3022069968-2026-03-06.

Chicago

Argus HQ Research. "Form 483 Record: Ascendis Pharma LLC, March 6, 2026 — 2 Citations." Digital Empire Holdings LLC. Accessed August 17, 2026. https://argushq.ai/483/ascendis-pharma-3022069968-2026-03-06.

BibTeX

@misc{argushq_argushq_ai_483_ascendis_pharma_3022069968_2026_03_06_2026,
  title = {Form 483 Record: Ascendis Pharma LLC, March 6, 2026 — 2 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/ascendis-pharma-3022069968-2026-03-06},
  note = {Accessed: August 17, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗