Sterinova Inc. – FDA Inspection, Jan 31, 2017

Record Details

This FDA Inspection record concerns Sterinova Inc., with an inspection on January 31, 2017, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Sterinova Inc.
Inspection Date: January 31, 2017
Product Type: Human Drugs
Office: Office of Inspections and Investigations
People: Felix Maldonado (FDA Associated Person)
Tajah L. Blackburn (FDA Associated Person)

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ID · 81ba2e90-3cd6-41e7-bf67-21670bf4c0d5

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1002548
FDA center: Human Drugs
Project area: Generic Drug Evaluation
Outcome: Form 483 issued

FDA Citations

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

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FDA Inspection

Sterinova Inc.January 31, 2017