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•United States

Apothecus Pharmaceutical Corp., Hicksville, NY – FDA Inspections

Inspection records and compliance data for Apothecus Pharmaceutical Corp. in Hicksville, New York. 9 FDA inspections on record (2 OAI), 3 Form 483s, 1 warning letter, last inspected November 15, 2024.

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Company Profile

This profile covers Apothecus Pharmaceutical Corp. based in Hicksville, New York, United States.

FDA Inspection History

FDA inspections
9
OAI
2
VAI
1
NAI
5
Unclassified
1
Form 483s
3
Warning letters
1

First inspected July 21, 2009. Last inspected November 15, 2024.

Most cited issue areas

  • Computer control of master formula records3 inspections
  • Investigations of discrepancies, failures3 inspections
  • Procedures not in writing, fully followed3 inspections

FDA inspections (9)

DateResultFDA center(s)Insp. #
November 15, 2024VAIHuman Drugs · Drug Quality Assurance1251530
October 6, 2023OAIHuman Drugs · Drug Quality Assurance1220590
May 17, 2021OAIHuman Drugs · Drug Quality Assurance1142449
April 30, 2019Not classifiedHuman Drugs · Drug Quality Assurance1087948
July 23, 2014NAIHuman Drugs · Drug Quality Assurance889126
June 27, 2012NAIHuman Drugs · Drug Quality Assurance792821
May 25, 2011NAIHuman Drugs · Drug Quality Assurance726516
March 10, 2010NAIHuman Drugs · Drug Quality Assurance650614
July 21, 2009NAIHuman Drugs · Drug Quality Assurance601368
FDA documents

Form 483s (4)

  • Form 483s · November 15, 2024
  • Form 483s · October 6, 2023
  • Form 483s · May 17, 2021
  • Form 483s · April 30, 2019

Warning Letters (1)

  • Warning Letters · April 30, 2019
People (5)
Meredith P. Soehl
Person
Sony Mathews
Person
Diana Amador-Toro
Person
Brandy N. Lepage
Person
Bijoy Panicker
Person
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Jamol Laboratories, Inc.
Sinsin Pharmaceutical Co., Ltd.
Abon Pharmaceuticals, LLC
Linde, Inc. dba Praxair, Inc
Greene Respiratory Services, Inc.
AIRGAS USA, LLC
Company Information

Name

Apothecus Pharmaceutical Corp.

FEI Number

3001746542

Address

485 S Broadway Ste 27, Hicksville, New York 11801, United States

Country

United States

ID: d37c243b-2226-4d18-9931-7a3b915e3199

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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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