1Other quality system
EMPLOYEE{S) NAME AND TITLE (Print or Type)
Inspection Record
Bioiberica, S.A.U — FDA 483 Findings
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
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.
