1Deviation, CAPA, and investigation
You failed to take adequate corrective action preventative action (CAPA) for a manufacturing system, resolution of an aberrant condition in a timely manner.
Inspection Record
Loba biotech GmbH — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
3Equipment and facility
Equipment, facilities and a utility system in support ofm@ drug substance manufacture are not adequately maintained or are deficient in design.
4Training and personnel
Supervisory oversight on the training ofthe employees is inadequate.
5Validation and qualification
Validations in support of@@ drug substance manufacture are deficient.
6Other quality system
A standard operating procedure is not available or is deficient in support of©® drug substance manufacture.
About this record
Extracted automatically from the document US FDA published on 2026-10-19. 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.
