FDA 483 - National Chemical Laboratories - May 26, 2023

National Chemical Laboratories in Philadelphia, PA, an OTC drug manufacturer, was cited with six observations during an FDA inspection. The observations primarily concern a lack of written procedures and validation studies for quality control, stability testing, supplier qualification, equipment cleaning, and process controls for their Afia hand sanitizer products. Additionally, facility maintenance issues were noted, including water-stained ceilings and unprotected overhead lights.