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Bio-Tech Pharmacal, Inc FDA Inspection Record

FEI 1910279 · Inspections, Form 483s, warning letters and import refusals

Bio-Tech Pharmacal, Inc is an FDA-inspected facility (FEI 1910279) located in Fayetteville, AR, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 11, 2025: Voluntary Action Indicated (VAI)
Inspections on record
6 (2 VAI, 4 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

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 11, 2025Voluntary Action Indicated (VAI)Appropriate tests, examinations; certificate of analysis (21 CFR 111.75(a)(2))
Apr 21, 2021No Action Indicated (NAI)No citations listed
Sep 14, 2016No Action Indicated (NAI)No citations listed
Sep 14, 2016Voluntary Action Indicated (VAI)Master manufacturing record - each batch (21 CFR 111.205(a))
Quality control - ensure quality; package, labeled, master record (21 CFR 111.105)
Feb 2, 2011No Action Indicated (NAI)No citations listed
Nov 14, 2008No Action Indicated (NAI)No citations listed

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
Bio-Tech Pharmacal, Inc
Location
Fayetteville, AR (US)
Source
inspections

FDA data resources

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