Inspection Record

Aurobindo Pharma Limited Unit 1 — FDA 483 Findings

US FDAInspected 2021-08-12Published 2021-08-24 3 findingsEquipment and facilityOther quality system

Inspectors Rita K KabasoThe inspectors who signed the published document.Inspector lookup

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

Findings

1Equipment and facility

Equipment not proper ly maintained Spec.ifically, on August 2°il, 2021, du·· (Technical) batch water was observed leakin ' from the nto the production floor is unknown h 1as been .leaking.

2Other quality system

Pl'oposcd changes arc not adcqunl'cly evalua ted.

3Other quality system

Quality related activities are not documented at the time of performance.

About this record

Extracted automatically from the document US FDA published on 2021-08-24. 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 1 company profile — full history US FDA documents, 2021 Go to Findings search