FDA 483 - Natures Formulae Health Products Ltd. - November 03, 2023

Natures Formulae Health Products Ltd. in Kelowna, a manufacturer of OTC drug products, was cited for significant deficiencies in its production and process controls. The inspection revealed failures in identity and finished product testing, lack of validated systems and qualified equipment, and inadequate written procedures for annual product reviews and equipment cleaning. These issues indicate a lack of adherence to good manufacturing practices.