FDA EIR - Johnson & Johnson Consumer Inc - October 08, 2015

An FDA inspection of Johnson & Johnson Consumer Inc. (formerly Neutrogena Corporation) was conducted from October 5 to October 8, 2015. This was a comprehensive current Good Manufacturing Practices (cGMP) surveillance inspection, performed under Compliance Program 7356.002 Drug Process Inspections, focusing on the company's Quality, Materials, Laboratory, and Production systems. The firm manufactures over-the-counter (OTC) drug products, including sunscreens and acne treatments. The inspection resulted in one significant observation (FDA-483). The primary deficiency identified was that drug products were not stored under appropriate temperature conditions, which could compromise their identity, strength, quality, and purity. This directly contravenes cGMP requirements for product integrity. Following the observation, the site director, Johnny Munoz Camps, committed to providing a written response to the Los Angeles District Office (LOS-DO) within fifteen business days. The inspection was classified as Voluntary Action Indicated (VAI), signifying that the agency expects the company to voluntarily address and correct the identified storage deficiencies to ensure compliance with regulatory standards for drug product storage.