Kopalle Pharma Chemicals Pvt Ltd. – FDA Inspection, Oct 13, 2017

Record Details

This FDA Inspection record concerns Kopalle Pharma Chemicals Pvt Ltd., with an inspection on October 13, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Kopalle Pharma Chemicals Pvt Ltd.
Inspection Date: October 13, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Freddy Ortiz Colon
Lisa B. Orr (Issuing Officer)

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ID · 6e014be0-7702-4acc-86be-80765e8794bc

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1028730
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

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FDA Inspection

Kopalle Pharma Chemicals Pvt Ltd.October 13, 2017