FDA 483 - McNeil Healthcare, LLC - November 02, 2010

This FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in quality control, manufacturing processes, and documentation.

**Observation 1** notes that the responsibilities and procedures for the quality control unit are not fully followed. This includes dissolution failures for Motrim IB 200 mg capsules (batch SHC003 and bulk lot SOA237), and issues with Benadryl Allergy Ultra Tab (DAU) product lots AJA005 and SH6012, which had "musty/moldy" complaints. The investigation into these complaints revealed that some affected lots were excluded from a recall list due to manual processes and human error in releasing lots ASA066 and ASAW2. Furthermore, McNeil Las Piedras Quality Management allegedly used informal processes for product release, and the investigation did not fully address their responsibilities for lots ASA201, ASA066, ADA194, and AUAI94. A potential root cause of contaminated pallets from a supplier was not further investigated. The recall list used was not properly verified, leading to 26 additional recalls of McNeil Benadryl and Tylenol products.

**Observation 3** states that drugs are failing to meet quality standards, and there is no assurance that established materials prevent the approval of further products. This is exemplified by Benadryl Allergy Ultratabs (BAUT) lots AJA001 and SJA00