Atlas

FDA-Inspected Site

Ascent Pharmaceuticals Inc

13 FDA inspections are on record for Ascent Pharmaceuticals Inc in Central Islip, United States.

Clean· No action indicated

Central Islip, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-02-03.

At a glance

Inspections

13

Form 483s

6

EIRs

4

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Jan 2025 – 3 Feb 2025Human DrugsClean
1 Aug 2024 – 9 Aug 2024Human Drugs483View 483 →
12 Sep 2022 – 15 Sep 2022Human Drugs483View 483 →
5 May 2022 – 13 May 2022Human DrugsClean
25 Oct 2021 – 1 Nov 2021Human DrugsClean
17 Sep 2020 – 13 Oct 2020Human Drugs483View 483 →
5 Nov 2018 – 7 Nov 2018Human DrugsClean
23 Jul 2018 – 27 Jul 2018Human DrugsClean
6 Feb 2018 – 21 Feb 2018Human DrugsClean
22 Jun 2016 – 28 Jun 2016Human DrugsClean
28 Oct 2015 – 9 Nov 2015Human Drugs483View 483 →
12 Sep 2013 – 26 Sep 2013Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

9 Aug 2024
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Bijoy Panicker, Amatul H Marium, Raihan A Chowdhury, Luxuly Abraham, Wei Yang

9 Aug 2024
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Bijoy Panicker, Amatul H Marium, Raihan A Chowdhury, Luxuly Abraham, Wei Yang

9 Aug 2024
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Bijoy Panicker, Amatul H Marium, Raihan A Chowdhury, Luxuly Abraham, Wei Yang

9 Aug 2024
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Bijoy Panicker, Amatul H Marium, Raihan A Chowdhury, Luxuly Abraham, Wei Yang

9 Aug 2024
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Bijoy Panicker, Amatul H Marium, Raihan A Chowdhury, Luxuly Abraham, Wei Yang

Investigators

FDA investigators tied to this site in the record.

Tanya R Syffrard3 insp.
Bijoy Panicker2 insp.
Gam S Zamil2 insp.
Sony Mathews2 insp.
Amatul H Marium1 insp.
Raihan A Chowdhury1 insp.
Luxuly Abraham1 insp.
Wei Yang1 insp.
Tyanna N Hadley1 insp.
Feiyan Jin1 insp.
Karen L Kosar1 insp.
Srinivas Chennamaneni1 insp.
Jay T Wong1 insp.
Alice S Tsao1 insp.
Anthony Kovalenko1 insp.
Robert C Horan1 insp.
Satheesh Thomas1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.68(b)Cited across public-safe Form 483 observations4x
21 CFR 211.142(b)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.68(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.52Cited across public-safe Form 483 observations1x
FDCA 505-1(f)(4)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Ascent Pharmaceuticals Inc's 6 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat