Inspection Record

Catalent Brussels — FDA 483 Findings

US FDAInspected 2021-10-26Published 2022-01-14 3 findingsEquipment and facilityOther quality systemLaboratory and QC controls

Inspectors Wayne Seifert · Lindsey BrownThe 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 and facilities used in the manufacture of drug product are not adequately maintained or appropriately designed to facilitate operations for their intended use.

2Other quality system

Standard operating procedures are not followed or are deficient.

About this record

Extracted automatically from the document US FDA published on 2022-01-14. 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.

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