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USAntibiotics LLC FDA Inspection Record

FEI 1047293 · Inspections, Form 483s, warning letters and import refusals

USAntibiotics LLC is an FDA-inspected facility (FEI 1047293) located in Bristol, TN, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 4, 2025: Voluntary Action Indicated (VAI)
Inspections on record
6 (1 VAI, 5 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest Feb 15, 2013
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 4, 2025Voluntary Action Indicated (VAI)Procedures for non-sterile drug products (21 CFR 211.113(a))
Following/documenting laboratory controls (21 CFR 211.160(a))
Systems in place to comply with verification requirements (FDCA 582(b)(4))
Oct 17, 2024No Action Indicated (NAI)No citations listed
Dec 13, 2019No Action Indicated (NAI)No citations listed
Jan 9, 2015No Action Indicated (NAI)No citations listed
Oct 22, 2012No Action Indicated (NAI)No citations listed
Mar 3, 2011No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Feb 15, 2013Class IID-239-2013Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC…
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at…

FDA record score

6 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

2 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIApr 4, 20256 x 16
Class II recall D-239-2013, this FEI as the recalling firmFeb 15, 201310 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
USAntibiotics LLC
Location
Bristol, TN (US)
Source
inspections

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.