Inventia Healthcare Pvt Ltd. – FDA Inspection, Feb 22, 2019

Record Details

This FDA Inspection record concerns Inventia Healthcare Pvt Ltd., with an inspection on February 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Inventia Healthcare Pvt Ltd.
Inspection Date: February 22, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Janete F. Guardia (Issuing Officer)

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ID · b9e7e32f-6958-40cb-9f14-c5c7691213c7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1080493
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 314.80(b)Failure to develop written procedures
21 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR

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FDA Inspection

Inventia Healthcare Pvt Ltd.February 22, 2019