FDA WARNING_LETTER - Vienna Beauty Products Co - December 22, 2011

The FDA conducted an inspection of Vienna Beauty Products' cosmetic manufacturing facility from October to December 2011, identifying significant violations. The firm's Triple Lanolin Aloe Vera Foot Scrub was found to be adulterated under Sections 601(a) and 601(c) of the Federal Food, Drug, and Cosmetic Act. Product analysis revealed excessive microbial contamination, including high Aerobic Plate Counts (150,000 APC/g and 98,000 APC/g) and the presence of pathogens like Pseudomonas aeruginosa and Burkholderia multivorans/B. cepacia group, rendering it injurious to users. This adulteration was compounded by observed insanitary conditions, such as filth and dust on manufacturing equipment, sediment on production kettles, and extremely infrequent cleaning of the production floor (annual), kettles (last cleaned 15 years ago), and storage tanks/totes (last cleaned over 20 years ago). Further deficiencies included a lack of routine microbial safety evaluation for starting materials, improper installation of fixtures leading to condensate contamination, failure to regularly test water used as an ingredient, inadequate maintenance and sanitation of equipment and production areas, improper storage of raw materials, absence of established manufacturing controls and written instructions, and a failure to conduct product sampling for quality and microbial testing (ceased in 2007, with 22 prior contamination instances uninvestigated). The firm also failed to maintain complete control records. The FDA deemed the firm's initial response inadequate and requires prompt corrective action, investigation into the causes of violations, and prevention of recurrence. A written response detailing corrective actions and timelines is required within fifteen working days to avoid potential enforcement actions like seizure or injunction.