Comment from Lonza
AnonymousSupportBusiness
Summary: Lonza, a pharmaceutical manufacturing company, is submitting comments regarding the FDA's draft guidance on responding to Form 483 observations. The submission includes a consolidated set of comments from the organization to provide feedback on the proposed guidance.
On behalf of the Lonza organization, we would like to submit our comments for the FDA draft guidance titled "Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry." Please see attached PDF for the consolidated comments from Lonza.