McNeil Healthcare, LLC – FDA 483, Sep 9, 2002

This FDA Form 483 document outlines two observations made during an inspection. The facility failed to adhere to established sampling plans.

Specifically, for Motrin IB Gelcaps 100 count, the stability sampling plan for 2001 was not followed, as the first lot of the first three marketed lots was not placed on stability, contrary to NDA commitments and the "SOP Stability Study Design and Acquisition."

Additionally, the first lots of nine products packaged with caps featuring a new liner were not placed on stability as required by a Change Control record. These products include Extra Strength Tylenol (caplets 24 count, lot FBA 224; gelcaps 24 count, lot FBA 233; tablets 30 count, lot FBA 247), Regular Strength Tylenol 100 count (lot FBA 246), Tylenol PM (geltabs 24 count, lot FBA 219; gelcaps 24 count, lot FBA 251), Motrin (tablets 24 count, lot FBA 294; caplets 24 count, lot FBA 304), and Tylenol Soft Chewable Grape tablets 30 count (lot FCA002).

The second observation notes that deviations from written sampling plans were not recorded. A Nonconformance Investigation Report (NCR) was