Vilvet Pharmaceuticals Inc. – FDA Inspection, Jun 27, 2018

Record Details

This FDA Inspection record concerns Vilvet Pharmaceuticals Inc., with an inspection on June 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Vilvet Pharmaceuticals Inc.
Inspection Date: June 27, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Christina K. Theodorou (FDA Associated Person)

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ID · 8a3f14f8-5509-43a1-a063-624529fde4d4

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1057062
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

Vilvet Pharmaceuticals Inc.June 27, 2018