Women's Health Care Inc – FDA Inspection, Jul 21, 2017

Record Details

This FDA Inspection record concerns Women's Health Care Inc, with an inspection on July 21, 2017, issued by the Los Angeles District Office, covering human drugs.

Company: Women's Health Care Inc
Inspection Date: July 21, 2017
Product Type: Human Drugs
Office: Los Angeles District Office
Person: Julian C. Hanson (Issuing Officer)

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ID · e3959823-e04b-4e50-8bd8-ddf6da0a30cb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1018982
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.57(d)Bioequivalence samples
21 CFR 312.60FD-1572, protocol compliance

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FDA Inspection

Women's Health Care IncJuly 21, 2017