Inspection Record

Rentschler Biopharma SE — FDA 483 Findings

US FDAInspected 2023-03-07Published 2023-05-05 3 findingsOther quality systemContamination controlQuality unit oversight

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

Findings

1Other quality system

lblT4l l b)l.il)------,_ Nine bags of rejected biological intennediatel _____., atc ____l bags 3 - 11) were not promptly moved to the reject cage at the time ofrejection on or about l/13/2022 as required by SOP 01027 "Quarantine Store", section 6.3.3.

2Contamination control

Procedures to prevent microbial contaminations are inadequate.

3Quality unit oversight

Responsibilities ofthe quality unit are not always fully followed.

About this record

Extracted automatically from the document US FDA published on 2023-05-05. 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.

Other records for this company

2022-02-15 · US FDA · 7 findings
Rentschler Biopharma SE findings history — including this company's other documents US FDA documents, 2023 Go to Findings search