FDA Finds Serious Violations at Skin Care Firm

Bioque Technologies, Inc. & Vouray, Inc., Blacksburg, VA, have been issued cited by the FDA for “serious violations of the Federal Food, Drug and Cosmetic Act” after on-site inspections and a website evaluation.
 
FDA reviewed product labels for Vouray Serum HA and Vouray Serum K1 products following the inspections of the company’s facility. Additionally, FDA reviewed websites (www.bioque.com and www.vouray.com) in August 2016.
 
FDA has determined that claims on product labels and the firm’s websites establish that Serum RV-EGF Serum, Day Skin Defense, Serum HA, Serum XL, C-Plus Moisturizing Cream, Serum Rejuvenate, and Multi-Peptide Anti-Wrinkle Serum are drugs as outlined by the Act.
  
In addition, FDA said in its letter “Even if your Serum RV-EGF Serum, Day Skin Defense, Serum HA, Serum K1, Serum XL, C-Plus Moisturizing Cream, Serum Rejuvenate, and Multi-Peptide Anti-Wrinkle Serum products did not have claims which make them unapproved new drugs, the products, and any other cosmetic products you manufacture, are adulterated cosmetics within the meaning of section 601(c) of the Act [21 U.S.C. § 361(c)].”
 
FDA’s inspection revealed that the equipment for processing, transfer, and filling; and the containers for holding raw and bulk cosmetic materials and processing final product are not cleaned and sanitized prior to use. Processing equipment, containers, and multiple utensils used for cosmetic manufacture were noted to have dried material and residual filth on the interior and/or cosmetic contact surfaces.
 
FDA also noted that cosmetic ingredients were not stored and handled in a manner which prevents their contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture. For example, FDA said that a container of Kombuchka labeled for storage at 4 – 7 C was stored at ambient air temperature.
 
According to FDA, live ant-type insects were observed in, but not limited, to areas in the manufacturing, filling, and warehouse. Live ants were also noted on the lid of a bulk formulation container for Moisturizing Base Gel. An approximate 1.5 inch gap was observed along the entire length of a loading dock door along the West wall of the general manufacturing, filling, and warehouse area.
 
In addition FDA observed that two out of three containers of a preservative in use at your firm had an expiration date of 09/13/2010 and another container had an expiration date of 04/30/2009.
 
“It is your responsibility as a manufacturer to ensure that your products are not capable of supporting microbial growth under the conditions of customary use,” said FDA in its letter.