Inspection Record

Biocon Sdn. Bhd. — FDA 483 Findings

US FDAInspected 2021-09-24Published 2021-10-25 4 findingsEquipment and facilityOther quality systemCleaning validation

Inspectors Wayne Seifert · Yetao JinThe 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

Facilities and equipment are not adequately validated and maintained for .__~~~~~~~~~~___, manufacture.

2Other quality system

tic behavior and monitorin is not adeguate.

3Other quality system

Standard operating procedure is inadequate.

4Cleaning validation

Cleaning validations in support o Specifically, indicated the source of the leak was respectively.

About this record

Extracted automatically from the document US FDA published on 2021-10-25. 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

2024-09-27 · US FDA · 7 findings2023-07-20 · US FDA · 6 findings2020-02-21 · US FDA · 3 findings2018-02-15 · US FDA · 6 findings
Biocon Sdn. Bhd. company profile — full history US FDA documents, 2021 Go to Findings search