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WARNING LETTER

(587251)

 

 

 

Dear Mr. Barth:

 

On November 28, 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 Anaheim, CA, including your Intenze Advanced Tattoo Ink-True Black product. Also on November 28, 2018, FDA collected samples of tattoo ink products manufactured and distributed by your firm from one of your customers in Beloit, WI, including your Intenze – Raw Umber Light 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 customers, we identified serious violations of the Act.  You can find the Act and applicable regulations through links in FDA’s Internet homepage at www.fda.gov.

 

Adulterated Cosmetics

 

FDA analyzed the products collected from your customers noted above to determine if the products contain microbial contamination.  FDA’s microbial analysis of the Intenze Advanced Tattoo Ink-True Black product (Lot (b)(4), FDA Sample #1092208) collected intact and unopened from your Anaheim, CA customer revealed significant microbial contamination. The microbial contamination of this product causes the 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.

 

Sample #1092208 was found to exceed (b)(4) colony forming units/gram (cfu/g).  In addition, the sample contained the microorganisms Pseudomonas andersonii, Oligella ureolytica, and unidentified members of the genus Methylobacterium.  The noted high microbial contamination of your Intenze Advanced Tattoo Ink-True Black product (Lot (b)(4)) is a significant health and 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.

 

We also note that our microbial analysis of your Intenze – Raw Umber Light product (Lot (b)(4), FDA Sample # 1039248), collected intact and unopened from your Beloit, WI customer revealed low levels of microorganisms including Bacillus circulans, and unidentifiable, gram-negative, oxidase positive bacteria. 

 

FDA recommends you develop a remediation plan to prevent future product contamination.

 

Misbranded Cosmetics

 

FDA has reviewed the product labeling for the samples collected from your Anaheim, CA and Beloit, WI customers. Based on our review, we have determined that your Intenze Advanced Tattoo Ink-True Black (Lot (b)(4)) and Intenze – Raw Umber Light (Lot (b)(4)) products are misbranded within the meaning of section 602(a) of the Act in that the labeling is false or misleading in any particular because the products are labeled “sterile” but were found to contain microorganisms.  Products labeled as “sterile” are expected to be free of viable microorganisms.  Therefore, use of the term “sterile” in regard to your Intenze Advanced Tattoo Ink-True Black (Lot (b)(4)) and Intenze – Raw Umber Light (Lot (b)(4)) products is false and misleading.

 

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 or misbranded 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 Intenze Advanced Tattoo Ink – True 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).”
• 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.

 

Please send your reply to the 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 [email protected]. Please reference Warning Letter #587251 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