Bio-Tech Pharmacal, Inc, Fayetteville, AR – FDA Inspections

Inspection records and compliance data for Bio-Tech Pharmacal, Inc in Fayetteville, Arkansas. 6 FDA inspections on record, 1 Form 483, last inspected April 11, 2025.

Company Profile

This profile covers Bio-Tech Pharmacal, Inc based in Fayetteville, Arkansas, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 2
NAI: 4
Form 483s: 1
Warning letters: 0

First inspected November 14, 2008. Last inspected April 11, 2025.

Most cited issue areas

Appropriate tests, examinations; certificate of analysis1 inspection
Master manufacturing record - each batch1 inspection
Quality control - ensure quality; package, labeled, master record1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
April 11, 2025	VAI	Foods & Cosmetics · Food Composition, Standards, Labeling, and Economics	1266502
April 21, 2021	NAI	Foods & Cosmetics · Food Composition, Standards, Labeling and Econ	1141479
September 14, 2016	VAI	Foods & Cosmetics · Food Composition, Standards, Labeling and Econ	985162
September 14, 2016	NAI	Foods & Cosmetics · Food Composition, Standards, Labeling and Econ	985160
February 2, 2011	NAI	Human Drugs · Drug Quality Assurance	707926
November 14, 2008	NAI	Human Drugs · Drug Quality Assurance	550126

FDA documents

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

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