Smile Wholesale Inc. – FDA Inspection, Dec 22, 2017

Record Details

This FDA Inspection record concerns Smile Wholesale Inc., with an inspection on December 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Smile Wholesale Inc.
Inspection Date: December 22, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Marian E. Ramirez (Company Rep)

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ID · 23524168-28c5-480f-a747-76735a43b23b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1036076
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.58Buildings not maintained in good state of repair
21 CFR 211.142(b)Storage under appropriate conditions
21 CFR 211.22(a)Lack of quality control unit

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FDA Inspection

Smile Wholesale Inc.December 22, 2017