FDA EIR - Sage Products, LLC - September 01, 2016

An FDA inspection of Sage Products Inc. in Cary, IL, was conducted from June 2 to September 1, 2016, following concerns about Burkholderia cepacia clusters potentially linked to the firm's Chlorhexidine Gluconate products. The inspection covered drug manufacturing, repackaging, medical devices, and cosmetics, operating under Compliance Programs 7356.002, 7356.002B, 7382.845, and 7329.001.

The inspection revealed significant deficiencies, resulting in a 6-item FDA-483. Main violations included the firm's inability to reliably detect objectionable microorganisms in drug products using existing microbiology test methods, inadequate validation of supplier Certificates of Analysis, and failure to ensure equipment was properly cleaned and sanitized to prevent contamination. Specifications for raw materials used in Antiseptic Oral Rinse were also found to be insufficient. For medical devices, issues were identified in process validation for paste drying and risk analysis for specific oral care products.

During the inspection, Sage Products initiated multiple voluntary recalls for various drug and cosmetic cloth products, such as Comfort Shield Barrier Cream Cloths and 2% Chlorhexidine Gluconate Cloths, due to confirmed or potential Burkholderia cepacia contamination. These recalls expanded on previous contamination-related recalls in 2014, 2008, and 2006. The company committed to providing written responses with proposed corrective actions for all noted deficiencies within 15 days.