FDA 483 - Haleon US Inc. - July 08, 2011

This FDA Form 483 document details numerous violations and deficiencies observed during an inspection of a drug product manufacturing and packaging facility. The facility, identified as NCH-Lincoln, manufactures and packages various drug products, including Excedrin, Bufferin, and No Doz, as well as DEA schedule products.

**Key Violations and Observations:**

* **Quality Control Unit Failures (Observation 1):** The Quality Unit (QU) failed to adequately monitor Quality Systems, evidenced by recurring issues, NDA Field Alerts, and recalls for similar problems over several years. * **Inadequate Investigations (Observations 2, 3, 7, 8):** * Failure to open deviation investigations for numerous "critical" consumer complaints of foreign products found in drug products. * Investigations did not extend to all potentially affected batches of product. Examples include mix-up complaints for Excedrin Migraine Tablets/Caplets and Excedrin Extra Strength Caplets/Gelcaps. This is a repeat deficiency from a previous inspection. * Failure to identify the root cause of customer complaints for solid dosage form foreign tablets since at least 2009, despite continued evidence of mix-ups. Conclusions drawn in investigations were often not supported by evidence. * **Failure to File NDA Field Alerts (Observation 4):** The firm failed to submit NDA Field Alerts within three working days of identifying incidents where a drug product or