FDA EIR - Conklin Company, Inc. - October 24, 2012

An FDA inspection of Conklin Company, Inc. in Shakopee, MN, was conducted from October 18 to October 24, 2012. The inspection aimed to assess compliance with regulations governing dietary supplements and drug manufacturing, following previous Warning Letters in 2002 and 2003 concerning unapproved therapeutic claims on product labels and inadequate labeling for dietary supplements. Notably, the firm's Fortress Defensive Skin Cream had been classified as an over-the-counter drug.

The current inspection revealed continued significant non-compliance. Conklin Company was still manufacturing and marketing Fortress Defensive Skin Cream without proper drug product approval and without adhering to essential drug manufacturing regulations. Additionally, the company's promotional materials for various dietary supplements contained numerous unproven therapeutic claims, suggesting their efficacy in treating serious conditions such as cancer, diabetes, Alzheimer's, heart disease, and Parkinson's. Critical deficiencies identified included the absence of written procedures for production and process controls to ensure the identity, strength, quality, and purity of drug products, and a lack of established procedures for handling drug product complaints. The company was issued an FDA-483, detailing these observations and requiring the implementation of corrective actions to address these regulatory violations and ensure compliance with federal food, drug, and cosmetic laws.