IMPROVA HERBAL PRODUCTS – FDA Warning Letter, Sep 15, 2015

On December 15, 2015, the FDA issued a Warning Letter to Improva Herbal Products in Pune, India, following an inspection on September 14-15, 2015. The inspection revealed serious deviations from the Emergency Permit Control regulation (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114) for their acidified herbal juice products, including Ginger, Jamboo bij, Pomegranate, Arjunachhal, Tulsi, Wheat grass, Baeley, Haldi, Karela, and Nomi juices.

Key violations included: 1. **Lack of Scheduled Processes:** The firm failed to have scheduled processes established by a qualified person with expert knowledge in acidification and processing of acidified foods, as required by 21 CFR 114.83. Despite registering with the FDA and acquiring an FCE number, no scheduled processes were on file for their acidified products shipped to the U.S., violating 21 CFR 108.25(c)(2). 2. **Untrained Operators:** Operators of processing and packaging systems were not under the supervision of a person who had attended and satisfactorily completed an FDA-approved school, as required by 21 CFR 114.10.

These violations render the firm's acidified products adulterated under section 402(a)(4) of the Act.