Inspection Record

Bioiberica, S.A.U — FDA 483 Findings

US FDAInspected 2022-02-04Published 2022-06-09 5 findingsOther quality systemCleaning validationStability and storageQuality unit oversightDeviation, CAPA, and investigation

Inspectors Arsen KarapetyanThe inspectors who signed the published document.Inspector lookup

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

Findings

1Other quality system

EMPLOYEE{S) NAME AND TITLE (Print or Type)

2Cleaning validation

Cleaning procedures for equipment used in the campaign manufacture of drug substances are not validated to facilitated adequate cleaning and contamination prevention measures.

3Stability and storage

There is no written testing program designed to assess the stability characteristics of drug substances.

4Quality unit oversight

The quality control unit lacks responsibility to approve all procedures or specifications impacting on identity, strength, quality, and purity of drug substances.

5Deviation, CAPA, and investigation

Written records ofinvestigations into unexplained discrepancies do not always include conclusions and follow-up which are adequately justified.

About this record

Extracted automatically from the document US FDA published on 2022-06-09. 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.

Bioiberica, S.A.U company profile — full history US FDA documents, 2022 Go to Findings search