12.01.16
Bioque Technologies, Inc. & Vouray, Inc. Blacksburg, VA, were 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 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, transferring, and filling, and the containers for holding raw and bulk cosmetic materials and processing final product were 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 to prevent 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 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 a separate letter, the founder of Malibu, CA-based Osea Internacional was issued a warning letter. The FDA contends that the company’s Blemish Balm, Essential Corrective Complex, Brightening Serum, and Sea Vitamin Boost are being marketed as drugs.
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 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, transferring, and filling, and the containers for holding raw and bulk cosmetic materials and processing final product were 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 to prevent 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 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 a separate letter, the founder of Malibu, CA-based Osea Internacional was issued a warning letter. The FDA contends that the company’s Blemish Balm, Essential Corrective Complex, Brightening Serum, and Sea Vitamin Boost are being marketed as drugs.