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WARNING LETTER

Dynamic Color Inc MARCS-CMS 587250 —


Delivery Method:
Certified Mail
Product:
Cosmetics
Tattoos

Recipient:
Recipient Name
Darin Jenkins
Recipient Title
President
Dynamic Color Inc

200 Park Central Blvd. S Suite 5
Pompano Beach, FL 33064-2197
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740-3835
United States


SEP 18, 2019

 

WARNING LETTER

(587250)

 

Darin Jenkins

President

Dynamic Color

200 Park Central Blvd. S

Suite 5

Pompano Beach, Florida 33064-2197

 

 

Dear Mr. Jenkins:

 

On November 7, 2018, the U.S. Food and Drug Administration (FDA) collected samples of tattoo ink products manufactured and distributed by your firm from one of your customers in Chandler, AZ, including your Dynamic Color WD1 (White) and Dynamic Color BLK (Black) products. On December 12, 2018, FDA collected samples of tattoo ink products manufactured and distributed by your firm from one of your customers in Austin, TX, including your Dynamic Color BLK (Black) product. These products are intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, and as such, are cosmetic products as defined by section 201(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(i)]. Based on an analysis of products collected from your customer, we identified serious violations of the Act.  You can find the Act and applicable regulations through link in FDA’s Internet homepage at www.fda.gov.

 

FDA analyzed the products collected from your customers to determine if the products contain microbial contamination.  FDA’s microbial analysis of Dynamic Color BLK (Black) (Lot (b)(4), FDA Sample #1090185) collected intact and unopened from your customer in Chandler, AZ and of Dynamic Color BLK (Black) (Lot (b)(4), FDA Sample #1093554) collected intact and unopened from your customer in Austin, TX revealed significant microbial contamination. The microbial contamination of your Dynamic Color BLK (Black) (Lots (b)(4) and (b)(4)) product causes this product to be adulterated within the meaning of section 601(a) of the Act [21 U.S.C. § 361(a)] in that it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.

 

FDA microbial analysis of your Dynamic Color BLK (Black) (Lots (b)(4) and (b)(4)) revealed the presence of the high-virulence pathogen Bacillus cereus.  B. cereus can cause serious skin infection and endocarditis through cutaneous exposure.[1],[2],[3] The presence of B. cereus in your Dynamic Color BLK (Black, Samples #1090185 and 1093554) product is of significant regulatory concern.  Tattooing injects ink into the dermis layer of skin thereby bypassing the skins ability to protect the body from microbiological infection and increasing health risk to the recipient.[4],[5]

 

We also note that our microbial analysis of your Dynamic Color BLK (Black) (Lot (b)(4)) product revealed the presence of Staphylococcus equorum and Kocuria kristinae.

 

We acknowledge that you have recalled Dynamic Color BLK (Black) product (Lots (b)(4) and (b)(4)) due to microbial contamination.  FDA recommends you develop a remediation plan to prevent future product contamination.

 

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.

 

This letter is not an all-inclusive list of violations that exist in connection with your products.  It is your responsibility to ensure that all products manufactured, processed, packed, and/or distributed by your firm comply with the Act and its implementing regulations. 

 

We may take further action if you do not promptly correct these violations.  Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. 

 

In addition to the above deviations, we offer the following comments:

  • Your Dynamic Color BLK (Black) product declares the ingredient “(b)(4).” The declaration of ingredients must contain the common or usual name of the ingredient, as required by 21 CFR 701.3(c). The common or usual name for the ingredient “(b)(4)” is “(b)(4).”
  • Your Dynamic Color BLK (Black) and Dynamic Color WD1 (White) products do not declare the net quantity of contents in accordance with 21 CFR 701.13.
  • Please note that, in our Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for cosmetics, we recommend a number of guidelines for effective self-inspection that may assist cosmetic manufacturers to minimize the risk of adulteration. These guidelines are available at https://www.fda.gov/cosmetics/cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics.

You should respond in writing within 15 working days from your receipt of this letter.  Your response should outline 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. You should include in your response any documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.  If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

 

Your written response should be sent to U.S. Food and Drug Administration, Attention: Beth Tirio, Compliance Officer, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A.  If you have questions regarding this letter, you may contact Beth Tirio via email at Beth.Tirio@fda.hhs.gov. Please reference Warning Letter # 587520 on any submissions and within the subject line of any emails to us.

                                                                       

Sincerely,

/S/

William A. Correll

Director

Office of Compliance

Center for Food Safety and Applied Nutrition

 

 

 

[1] Ann Dermatol Venereol. 2017 Jan;144(1):45-48. doi: 10.1016/j.annder.2016.09.045. Epub 2016 Oct 26. [Bacillus cereus endocarditis and a probable cutaneous gateway]. [Article in French]

Soudet S, Becquart C, Dezoteux F, Faure K, Staumont-Salle D, Delaporte E. https://www.ncbi.nlm.nih.gov/pubmed/28341191

[2] J Clin Microbiol. 2012 Feb;50(2):519-21. doi: 10.1128/JCM.00657-11. Epub 2011 Nov 23.

Native valve Bacillus cereus endocarditis in a non-intravenous-drug-abusing patient. Thomas BS, Bankowski MJ, Lau WK. https://www.ncbi.nlm.nih.gov/pubmed/22116159

[3] Infect Control Hosp Epidemiol. 2012 Jul;33(7):666-71. doi: 10.1086/666334. Epub 2012 May 7. Association of Bacillus cereus infection with contaminated alcohol prep pads.

Dolan SA, Littlehorn C, Glodé MP, Dowell E, Xavier K, Nyquist AC, Todd JK. https://www.ncbi.nlm.nih.gov/pubmed/22669227

[4] Curr Probl Dermatol. 2017;52:30-41. doi: 10.1159/000450777. Epub 2017 Mar 10. Tattoo Infections, Personal Resistance, and Contagious Exposure through Tattooing. Serup J.

[5] MMWR Morb Mortal Wkly Rep. 2005 Dec 9;54(48):1233-5.

Outbreak of cutaneous Bacillus cereus infections among cadets in a university military program--Georgia, August 2004. https://www.ncbi.nlm.nih.gov/pubmed/16340940