FDA 483 - SKYTRONICS LED, Inc. - January 12, 2026

An FDA inspection of Skytronics Led, Inc, an OTC drug manufacturer in Burbank, CA, revealed significant deficiencies across its quality system, laboratory controls, and facilities. The firm lacks an independent quality unit, proper written procedures, adequate drug product testing and stability programs, and sufficient cleaning and maintenance protocols. These observations indicate a fundamental failure to adhere to current good manufacturing practices.