About this document

FDA Inspection Report: McNeil Healthcare by Brian Williams is a document available to read on EtoBox.

This document summarizes observations from an inspection of a drug manufacturing facility. Key points include: 1) Batch records for Motrin IB cores did not always match the approved application and failed to clearly identify granulation batches used. 2) Reconciliation records for compression batches were unclear about granulation materials used. 3) Quality assurance did not document or investigate failures and deviations from process validation batches. 4) Hold times were not established for bulk and

Author

Brian Williams

Language

EN