Inspections, Compliance, Enforcement, and Criminal Investigations

Bioque Technology, Inc & Vouray, Inc. 10/7/16

  

Department of Health and Human Services logo

 
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707

FEI: 3005583401 and 3007750520 

 

WARNING LETTER
CMS# 506050
 
October 7, 2016
 
Via UPS
 
Mr. Vittoria A. Bonomo, Secretary and Chairman of the Board
Bioque Technologies, Inc. & Vouray, Inc.
3862 South Main Street
Blacksburg, VA 24060
                                                                                                                                     
 
Dear Mr. Bonomo:
 
The Food and Drug Administration (FDA) conducted two (2) inspections of your firms at your facility located at 3862 South Main Street, Blacksburg, VA 24060 from May 31, 2016 to June 10, 2016.  During the inspection FDA collected product labels for your products, including your Vouray Serum HA and Vouray Serum K1. Based on our inspections and subsequent review of your product labeling, including your firm’s websites, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act). You may find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
 
Unapproved New Drugs
 
FDA reviewed your product labels for your Vouray Serum HA and Vouray Serum K1 products following the inspections of your facility. Additionally, FDA reviewed your websites at the internet addresses, www.bioque.com and www.vouray.com in August 2016 and has determined that you take orders on your websites for your products, including Serum RV-EGF Serum, Day Skin Defense, Serum HA, Serum XL, C-Plus Moisturizing Cream, Serum Rejuvenate, and Multi-Peptide Anti-Wrinkle Serum. The claims on your product labels and websites establish that the products are drugs under sections 201(g)(1)(B) and/or 201 (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.
 
Examples of some of the product label and website claims that provide evidence that your products are intended for use as drugs include:
 
On the Vouray Website
 
Serum UC
  • “Our Ultra 20% Anhydrous Vitamin C Serum supports the skin's use of oxygen to boost the natural cell metabolism…and capillary function…”
  • “Replenishes Vitamin C levels to support the continued production of collagen and elastin”  
Serum RV-EGF Serum
  • “…[S]erum RV performs better than cosmetic injections…”
  • “Easy, natural alternative to pricey injections!”
Day Skin Defense  
  • “[A]n all-natural powerful defense against damaging sun rays…”
  • “Works all day to protect your skin from harmful…DNA damage…”
 
On the Vouray Website and Serum HA product label
 
Serum HA 
  • “Promotes the production of collagen and elastin”
  • “Promotes blood microcirculation…”
 
On the Vouray Serum K1 label
 
Serum K1
  • “Banish bruises and prevent unsightly scars with Serum K1” 
On the Bioque website
 
Serum XL  
  • “[T]he BOTOX alternative that packs a peptide punch” 
  • “Argireline, a peptide that serves as a natural muscle relaxant, builds up in facial muscles over time…This key ingredient destresses facial muscles beneath the deepest layer of skin to reduce tightening around cavities caused by collagen and elastin deterioration, stopping the process that furrows and puckers the outer layer of skin into wrinkles.”
  • “Better than a needle? You betcha.—Get all the benefits without invasive toxins, the potential risk, and the high price tag. Plus, Serum XL goes where paralyzing injections can’t.” 
  • “#1 Botox TM Alternative, 30% multipeptide serum.”
C-Plus Moisturizing Cream
  • “[C]ollagen-stimulation superstar…”
  • “Best collagen producer—Vitamin C is essential to the active production of collagen. And CPlus really revs up your skin cells…”
Serum Rejeuvenate  
  • “A…antiaging serum that utilizes…Intensive Penetrating Complex…which helps activate collagen and elastin and repairing damaged proteins…Intensive Penetrating Complex encourages healthier skin cell replication for long-term repair and help protect healthy cells from future damage…”
Your above-listed products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
Adulterated Cosmetics
 
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)].  The conditions and practices observed and documented during the inspections cause your cosmetic products to be adulterated within the meaning of section 601(c) of the Act in that the products have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. It is a violation of section 301(a) of the Act [21 U.S.C. §331(a)] to introduce or deliver for introduction into interstate commerce an adulterated cosmetic. For example, the following observations were made:
 
1.    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.
 
2.    Your cosmetic ingredients are 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, while a container of Kombuchka was labeled for storage at 4 – 7 C, the container was stored at ambient air temperature.
 
3.    The physical facilities of your plant are not maintained in manner to prevent contamination of cosmetic products. 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.
 
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
In addition to the above violations, we also have the following comments. Our inspection revealed the following practices that may cause your products to become contaminated with filth or rendered injurious to health. Specifically:
 
1.    FDA observed that two out of three containers of Neolone 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. We note that FDA’s Draft Guidance for Industry on Cosmetic Good Manufacturing Practices (available at http://www.fda.gov/downloads/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/UCM358287.pdf) recommends that finished product samples as well as retained product samples are tested for adequacy of preservation against microbial contamination under reasonable conditions of storage and use.
 
2.    Your raw materials and in-process products are not stored and handled in a manner which prevents their mix-up with expired materials. Specifically, cosmetic ingredients and in-process products used in the manufacture of finished cosmetic products were observed to be stored in containers with no identification of contents, no lot or batch number identification, and no date of manufacture and/or expiration. Further, numerous expired cosmetic ingredients were observed in manufacturing areas for mixing and filling. For example, Bulk formulations of VOURAY SERUM UC and what appeared to be the bulk formulation for VOURAY SERUM RV were identified with a date of manufacture which exceeded the two year shelf-life. We note that FDA’s Draft Guidance for Industry on Cosmetic Good Manufacturing Practices (available at http://www.fda.gov/downloads/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/UCM358287.pdf) recommends that you use batch production control records, including: documentation of all ingredients (name, code, lot number, quantity, etc.) added to each batch; documentation of all production steps (for example, processing, handling, transferring, holding, and filling); and batch and finished product lot or control numbers.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented. 
 
Please send your written reply to the U.S. Food and Drug Administration, Attention: David P. Rice, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rice by phone at 410-779-5463 or by email at david.rice@fda.hhs.gov.
 
 
Sincerely yours,
/S/                                                           
Evelyn Bonnin
District Director
Baltimore District Office

Page Last Updated: 10/13/2016
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