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•United States

Ascent Pharmaceuticals Inc, Central Islip, NY – FDA Inspections

Inspection records and compliance data for Ascent Pharmaceuticals Inc in Central Islip, New York. 10 FDA inspections on record, last inspected February 03, 2025.

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Company Profile

This profile covers Ascent Pharmaceuticals Inc based in Central Islip, New York, United States.

FDA Inspection History

FDA inspections
10
OAI
0
VAI
6
NAI
3
Unclassified
1
Form 483s
0
Warning letters
0

First inspected December 6, 2012. Last inspected February 3, 2025.

Most cited issue areas

  • Calibration/Inspection/Checking not done1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection
  • Computer control of master formula records1 inspection

FDA inspections (10)

DateResultFDA center(s)Insp. #
February 3, 2025Not classifiedHuman Drugs1261247
August 9, 2024VAIHuman Drugs · Drug Quality Assurance1229681
September 15, 2022VAIHuman Drugs · Bioresearch Monitoring1179615
October 13, 2020VAIHuman Drugs · Drug Quality Assurance1132410
November 7, 2018NAIHuman Drugs · Bioresearch Monitoring1074882
July 27, 2018NAIHuman Drugs · Bioresearch Monitoring1067030
February 21, 2018NAIHuman Drugs · Drug Quality Assurance1047500
November 9, 2015VAIHuman Drugs · Drug Quality Assurance949174
September 26, 2013VAIHuman Drugs · Drug Quality Assurance852064
December 6, 2012VAIHuman Drugs · Drug Quality Assurance810516
FDA documents

Form 483s (3)

  • Form 483s · August 9, 2024
  • Form 483s · September 15, 2022
  • Form 483s · October 13, 2020

EIRs (4)

  • EIRs · September 15, 2022
  • EIRs · October 13, 2020
  • EIRs · November 7, 2018
  • EIRs · February 21, 2018
People (5)
Davies Kochunni
Person
Alice S. Tsao
Person
Joy Ann P. Matthias
Person
Karen L. Kosar
Person
Bijoy Panicker
Person
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GRANULES LIFE SCIENCES PRIVATE LIMITED
Ipca Laboratories Limited
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Company Information

Name

Ascent Pharmaceuticals Inc

FEI Number

3009518416

Address

400 S Technology Dr, Central Islip, New York 11722, United States

Country

United States

ID: a6df28ee-9e4e-4fae-8eed-dbe5eb870593

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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