ABR Laboratory LLC – FDA Inspection, Sep 13, 2024

Record Details

This FDA Inspection record concerns ABR Laboratory LLC, with an inspection on September 13, 2024, issued by the Florida District Office, covering human drugs.

Company: ABR Laboratory LLC
Inspection Date: September 13, 2024
Product Type: Human Drugs
Office: Florida District Office
Person: Kayla V. Sprague (FDA Associated Person)

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ID · 2d571f59-fe26-41e1-a7c9-8dd696fe73af

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1249178
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.165(e)Test methods
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

ABR Laboratory LLCSeptember 13, 2024