Oral Formulation Accept FDA PAI Inspection (“Zero deficiency”)
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Oral Formulation Accept FDA PAI Inspection (“Zero deficiency”)
KRB GMP team provided consulting services for a company to prepare and pass FDA for an oral preparation. The consulting services included gap analysis, re-validation consulting, personnel training, system optimization and enhancement, translation and technical support during the inspection. The product had a unique process and during the inspection the auditor demonstrated a very impressive inspection skill. Finally this project passed the FDA pre-approval inspection without deficiency, which was also the client's first FDA inspection.
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