FDA EIR - Neutrogena Corporation - May 16, 2013

An FDA inspection of Neutrogena Corporation, located at 5760 W 96th St, Los Angeles, CA, was conducted from May 14 to May 16, 2013. This routine, unannounced inspection focused on the company's compliance with current Good Manufacturing Practices (cGMP) for over-the-counter drug manufacturing, specifically reviewing Quality and Production systems. The inspection was carried out under Compliance Program 7356.002, which governs Drug Process Inspections.

Notably, the current inspection revealed no objectionable conditions, and consequently, no Form FDA-483 (Inspectional Observations) was issued. The inspection's classification was "No Action Indicated" (NAI), meaning no further regulatory actions are required from this specific inspection.

For context, a prior cGMP inspection in May 2010 had identified minor deviations, including departures from specified mixing temperatures, unsigned laboratory notebook entries, and chromatographic retention time discrepancies. Neutrogena reportedly took immediate corrective actions to address these previous issues, leading to an NAI classification for that inspection as well. The firm manufactures liquid profile class products.