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

Skytronics Led, Inc., an OTC drug manufacturer in Burbank, CA, was inspected and found to have significant deficiencies across its quality system, laboratory controls, and facility operations. The firm lacks a functional Quality Control Unit, fails to adequately test drug products for release and stability, and has critical issues with equipment cleaning, maintenance, and water system management. These observations indicate a severe lack of adherence to Good Manufacturing Practices, posing a high risk to drug product quality and patient safety.