Relevo, Inc. – FDA Inspection, Dec 1, 2016

Record Details

This FDA Inspection record concerns Relevo, Inc., with an inspection on December 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Relevo, Inc.
Inspection Date: December 1, 2016
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Meisha R. Sampson (Issuing Officer)

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ID · a346e554-6f77-4a6a-ba3a-32206a1095e2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 993557
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.166(a)Lack of written stability program
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

Relevo, Inc.December 1, 2016