FDA EIR - Neutrogena Corporation - August 12, 2010

An FDA inspection of Neutrogena Corporation, located at 5760 W 96th St, Los Angeles, CA 90045, was conducted from July 15, 2010, to August 12, 2010. This routine, unannounced inspection focused on the company's Quality, Laboratory, and Production Systems, as an OTC drug and cosmetic manufacturer. The regulatory framework for this inspection included Compliance Program 7356.002 for Drug Process Inspections and 7329.001 for Domestic and Import Cosmetics. The inspection identified several key deviations. These included a failure to maintain specified temperature ranges during the mixing process for multiple bulk lots of Body Clear Body Wash. Additionally, the inspection revealed that several laboratory notebook pages were not signed off upon project completion, and a discrepancy existed in chromatographic retention times between the Salicylic Acid Test Method and actual HPLC data. In response to these findings, the firm initiated immediate corrective actions for the observed issues. A single Inspectional Observation (FDA-483) was issued to Neutrogena management, who committed to further corrective measures. The inspection was classified as Voluntary Action Indicated (VAI), meaning the FDA expects the company to take appropriate voluntary actions to resolve the observations. A follow-up is anticipated in August 2011.