FDA 483 - Skyless LLC - May 16, 2022

Skyless LLC, a manufacturer of topical analgesic drug products in Ponce, PR, was cited with five observations during an FDA inspection. The firm demonstrated a severe lack of fundamental quality control, training, and written procedures across all aspects of its manufacturing operations, including quality unit responsibilities, employee training, equipment maintenance, production controls, and raw material testing. These deficiencies indicate a systemic failure to adhere to current good manufacturing practices.