Inspection Record

Aurobindo Pharma Limited Unit 4 — FDA 483 Findings

US FDAInspected 2016-09-16Published 2016-12-15 3 findingsLaboratory and QC controlsProcess validationOther quality system

Inspectors Scott T BallardThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory and QC controls

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity.

2Process validation

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

3Other quality system

The use ofinstruments and recording devices not meeting established specifications was observed.

About this record

Extracted automatically from the document US FDA published on 2016-12-15. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Aurobindo Pharma Limited Unit 4 company profile — full history US FDA documents, 2016 Go to Findings search