USAntibiotics LLC - Inspection Records

Inspection records and compliance data for USAntibiotics LLC in Bristol, Tennessee. 6 FDA inspections on record, 1 Form 483, last inspected April 04, 2025.

Company Profile

This profile covers USAntibiotics LLC based in Bristol, Tennessee, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 1
NAI: 5
Form 483s: 1
Warning letters: 0

First inspected March 3, 2011. Last inspected April 4, 2025.

Most cited issue areas

Following/documenting laboratory controls1 inspection
Procedures for non-sterile drug products1 inspection
Systems in place to comply with verification requirements1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
April 4, 2025	VAI	Human Drugs · Drug Quality Assurance	1268439
October 17, 2024	NAI	Human Drugs · Bioresearch Monitoring	1254251
December 13, 2019	NAI	Human Drugs · Drug Quality Assurance	1116163
January 9, 2015	NAI	Human Drugs · Drug Quality Assurance	910907
October 22, 2012	NAI	Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices	806122
March 3, 2011	NAI	Human Drugs · Drug Quality Assurance	716446

FDA documents

Form 483s (1)

Form 483s · April 4, 2025

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