Inspection Record

Biocon Ltd. — FDA 483 Findings

US FDAInspected 2020-01-24Published 2020-03-06 4 findingsQuality unit oversightEquipment and facilityMaterial and supplier controlOther quality system

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

Findings

1Quality unit oversight

Failure to fulfil the responsibilities of the Quality Control Unit.

2Equipment and facility

Equipment used in production operations are not adequately qualified.

3Material and supplier control

Failure to adequately handle, store and document material movement and status.

4Other quality system

Failure to perfonn adequately investigate non-confonnances.

About this record

Extracted automatically from the document US FDA published on 2020-03-06. 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.

Other records for this company

2021-12-12 · Health Canada · 9 findings2018-05-01 · US FDA · 7 findings2017-06-02 · US FDA · 9 findings2017-04-07 · US FDA · 5 findings
Biocon Ltd. findings history — including this company's other documentsAll US FDA findings US FDA documents, 2020 Go to Findings search
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