Fougera Pharmaceuticals LLC, Melville, NY – FDA Inspections

Inspection records and compliance data for Fougera Pharmaceuticals LLC in Melville, New York. 13 FDA inspections on record, 3 Form 483s, last inspected August 06, 2026.

Company Profile

This profile covers Fougera Pharmaceuticals LLC based in Melville, New York, United States.

FDA Inspection History

FDA inspections: 13
OAI: 0
VAI: 11
NAI: 1
Unclassified: 1
Form 483s: 3
Warning letters: 0

First inspected February 6, 2009. Last inspected August 6, 2026.

Most cited issue areas

Scientifically sound laboratory controls3 inspections
Cleaning / Sanitizing / Maintenance2 inspections
SOPs not followed / documented2 inspections

FDA inspections (13)

Date	Result	FDA center(s)	Insp. #
August 6, 2026	Not classified	Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices	1329668
December 8, 2023	NAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	1226533
August 10, 2022	VAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	1177370
August 8, 2019	VAI	Animal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices	1099025
May 29, 2018	VAI	Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices	1053495
November 10, 2016	VAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	992924
December 23, 2014	VAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	908064
October 31, 2013	VAI	Human Drugs · Drug Quality Assurance	857676
November 16, 2012	VAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	807660
June 15, 2012	VAI	Human Drugs · Bioresearch Monitoring	780240
February 9, 2011	VAI	Human Drugs · Bioresearch Monitoring	705760
January 12, 2010	VAI	Animal Drugs & Feeds, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance	636203
February 6, 2009	VAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	565460

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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