FDA WARNING_LETTER - shadow holdings - June 07, 2018

The FDA inspected Shadow Holdings LLC dba Bocchi Laboratories' cosmetic and OTC drug manufacturing facility from March 29 to June 7, 2018, following a Burkholderia cepacia outbreak linked to their Medline Remedy Essentials Cleanser No-Rinse Foam. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act.

The Medline Remedy Essentials Cleanser No-Rinse Foam was found to be adulterated under section 601(a) of the Act, as FDA analysis confirmed the presence of Burkholderia cepacia in samples from lots Mo7247 and Mo6691, posing a health risk, especially in hospital settings. The firm initiated multiple recalls for this and other cosmetic products due to potential B. cepacia contamination.

Furthermore, all manufactured cosmetic products were deemed adulterated under section 601(c) due to insanitary conditions. Environmental and water samples from the facility tested positive for various microorganisms, including Burkholderia cepacia and Pseudomonas species. The firm released finished cosmetic products, like Remedy Essential No-Rinse Cleansing Foam, that exceeded microbial specification limits ("TNTC" for Aerobic Plate Count and Yeast & Mold) without investigation. Insanitary practices observed included leaking tanks, dirty vents, broken ventilation, unmaintained equipment, pest infestations (live bird, fly-like insect), chipped conveyor belts, wastewater flooding with submerged hoses, and non-cleanable tape on equipment