Observations made by an FDA inspection in February at Rentschler’s site in Laupheim have been fully resolved, says Rentschler Biopharma.
This week, the US Food and Drug Administration (FDA) published results from an inspection at contract development and manufacturing organization (CDMO) Rentschler’s drug substance manufacturing site in Laupheim, Germany carried out in February.
The heavily-redacted Form 483 noted nine observations at the facility, with issues including failures to assure compliance with established specifications and standards in laboratory procedures, problems with equipment validation, a lack of adequate monitoring of environmental conditions of critical process equipment, and problems surrounding proper documentation.
While a Form 483 can be the first step towards more formal and critical FDA sanctions, such as warning letters or enforced halts in production, they are often resolved in a timely manner leading to no further actions.
And despite the sensationalist headlines made by some of the trade press, Rentschler told BioProcess Insider at the BIO 2022 convention in San Diego yesterday that the highlighted issues have been resolved and the matter is now closed.
“After receiving the Form 483 following the FDA inspection in February 2022, we immediately reviewed the observations made by the inspectors and responded with a plan of comprehensive measures to address the identified topics,” a spokesperson said.
“These were communicated to the FDA in an official response shortly after the inspection. Since then, our team has addressed all the processes and quality standards in accordance with the FDA’s requirements from the audit. During the whole process we have been in close contact with our client and the authority.
“On 14 June 2022 we received the official information from the FDA that the inspection has been closed without further comments.”
Keen readers will remember the Laupheim facility was subject to an expansion last year, with a 2,000 L bioreactor train added to the site’s capabilities.