Aventis Pharma Ltd. – FDA EIR, Mar 7, 2014

An FDA routine surveillance inspection of Aventis Pharma, Ltd., located in Holmes Chapel, United Kingdom, was conducted from March 3 to March 7, 2014. This inspection, carried out under regulatory framework CP 7356.002, aimed to assess the pharmaceutical manufacturer's compliance. The comprehensive inspection covered critical systems including quality, facilities and equipment, materials, production, packaging/labeling, and laboratory operations. The firm manufactures and distributes an Over-The-Counter (OTC) nasal spray for the U.S. market. No FDA Form 483 was issued, signifying that no significant objectionable conditions requiring formal observation were found. However, one discussion item was addressed with management: an unaddressed alarm on the stability chambers' monitoring system, caused by insufficient memory on its removable media storage. While no data integrity issues or temperature/humidity excursions were identified, management committed to revising written procedures to ensure all alarms are promptly addressed and to resolving the monitoring system's memory capacity. The inspection concluded with a recommendation for "No Action Indicated" (NAI), indicating a satisfactory outcome.