Inspection Record

Biocon Biosphere Limited — FDA 483 Findings

US FDAInspected 2024-06-14Published 2024-07-16 3 findingsLaboratory and QC controlsQuality unit oversightProcess validation

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

Findings

1Laboratory and QC controls

TYPE ESTABLISHMENT INSPECTED Manufact u rer Laborato1y controls do not include the establishment ofscientifically sound and appropriate test procedures designed to assure that diug products confo1m to appropriate standards of identity, strength, quality and purity.

2Quality unit oversight

In-process materials are not tested for identity, strength, quality and pmity and approved or rejected by the quality control unit after storage for long periods.

3Process validation

Your fnm failed to establish written procedures for production and process controls designed to assure that the drng products have the identity, strength, purity, and quality that they are purpo1ied or represented to possess.

About this record

Extracted automatically from the document US FDA published on 2024-07-16. 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.

Biocon Biosphere Limited company profile — full history US FDA documents, 2024 Go to Findings search