Inspection Record

Aurobindo Pharma Ltd. Unit 5 — FDA 483 Findings

US FDAInspected 2019-10-28Published 2019-11-20 3 findingsProcess validationEquipment and facilityAseptic processing and sterility assurance

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

Findings

1Process validation

Process validation does not always include inclusion and establishment of all process parameters that should be controlled for reproducible operations.

2Equipment and facility

Equipment for adequate control over micro-organisms is not always provided when appropriate for the manufacture, processing, and packing of drug substances.

3Aseptic processing and sterility assurance

The aseptic processing area is deficient regarding the system for monitoring environmental conditions.

About this record

Extracted automatically from the document US FDA published on 2019-11-20. 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 Ltd. Unit 5 company profile — full history US FDA documents, 2019 Go to Findings search