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FDA Inspection

Amnion LLCApril 8, 2026

Amnion LLC – FDA Inspection, Apr 8, 2026

Record Details

This FDA Inspection record concerns Amnion LLC, with an inspection on April 8, 2026, issued by the Baltimore District Office, covering biologics.

Company: Amnion LLC
Inspection Date: April 8, 2026
Product Type: Biologics
Office: Baltimore District Office
Person: La-tasha M. Gunter (Issuing Officer)

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ID · 81fb0257-5851-4854-9731-6d084f3e9a45

Inspection Facts

Inspection number: 1311494
FDA center: Biologics
Project area: Human Cellular, Tissue, and Gene Therapies
Outcome: Form 483 issued, view the record

FDA Citations

4

21 CFR 1271.160(b)(5)Monitoring systems
21 CFR 1271.190(d)(2)Documentation of activities
21 CFR 1271.210(d)(2)Verification elements
21 CFR 1271.270(a)Records maintained concurrently

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