Ulrike Schara, M.D. – FDA Inspection, Aug 4, 2017

Record Details

This FDA Inspection record concerns Ulrike Schara, M.D., with an inspection on August 4, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Ulrike Schara, M.D.
Inspection Date: August 4, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Craig T. Rybus (Company Rep)
Sherri N. Rohlf (Company Rep)

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ID · e678ca2a-e9ce-4859-840e-b9a1aa88f642

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1021225
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.60FD-1572, protocol compliance
21 CFR 312.62(b)Case history records- inadequate or inadequate

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FDA Inspection

Ulrike Schara, M.D.August 4, 2017