Inspection Record

Liva Pharmaceuticals Ltd. — FDA 483 Findings

US FDAInspected 2018-08-28Published 2018-09-10 4 findingsOther quality systemAseptic processing and sterility assuranceDeviation, CAPA, and investigation

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

Findings

1Other quality system

Failure to follow established and approved Standard Operating Procedures.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of sterile small volume parental drug products purporting to be sterile are not followed.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

About this record

Extracted automatically from the document US FDA published on 2018-09-10. 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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