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  5. Color Art, Inc. DBA Solid Ink - 587248 - 09/18/2019
  1. Warning Letters

WARNING LETTER

Color Art, Inc. DBA Solid Ink MARCS-CMS 587248 —

Delivery Method:
Certified Mail
Product:
Cosmetics
Tattoos
Recipient:
Recipient Name
Carlos F. Ferroni
Recipient Title
President
Color Art, Inc. DBA Solid Ink

16600 Northwest 54th Ave Suite 6
Miami Gardens, FL 33014-6105
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

(587248)

 

 

 

Dear Mr. Ferroni:

 

From December 4-12, 2018, the U.S. Food and Drug Administration (FDA) conducted an inspection of your tattoo ink manufacturing facility, Color Art, Inc. DBA Solid Ink, located at 16600 NW 54th Avenue, Unit #6, Miami Gardens, Florida 33014.  During the inspection, FDA collected samples of tattoo ink products you manufacture, including your Solid Ink-Super Red, Solid Ink-Matte Black, Solid Ink-White, Solid Ink-Yellow, and Solid Ink-Orange products. Furthermore, on December 12, 2018, FDA collected samples of tattoo ink products manufactured by your firm from one of your customers in Austin, TX, including your Solid Ink-Olive, Solid Ink-Deep Red, and Solid Ink-Diablo products. 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 within the meaning of 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 facility and your customer, our inspection of your facility, and our review of your product labels collected during the inspection, 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:  Microbial Contamination

 

FDA analyzed the products collected from your manufacturing facility in Miami Gardens, FL and from your customer in Austin, TX to determine if the products contain microbial contamination.  FDA’s microbial analysis of the Solid Ink-Diablo (Lot (b)(4), FDA Sample #1093551) product collected intact and unopened from your Austin, TX 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 #1093551 was found to contain the following Clostridium species: Clostridium clostridioforme, Clostridium ramosum, Bacillus pumilus, and B. megaterium. Clostridium species are bacteria that cause toxin-mediated infections, which means that both the toxin and the bacteria may cause illness.  Members of the genus Clostridium form an important part of the anaerobic microflora of humans, with the potential for causing infections.[1] Clostridium species may be present in a variety of clinical specimens.  Clostridium clostridioforme has been isolated from patients with osteomyelitis, bacteremia, liver abscess, and diabetic foot infections and can exhibit antibiotic resistance through the production of β-lactamase.[2]  Clostridium ramosum is most frequently identified in samples from the inner ear, blood, or absesses.[3]  Since your Solid Ink–Diablo (Sample #1093551) product contains anaerobic microorganisms, infection is likely to occur because of use of the contaminated inks, and also the tattoo application, is likely to place these microorganisms in anaerobic conditions that are conducive to their growth and invasion. 

 

The presence of Clostridium clostridioforme and Clostridium ramosum in your Solid Ink-Diablo product is a significant regulatory concern.  Tattooing injects ink into the dermis layer of skin thereby bypassing the skin’s ability to protect the body from microbiological infection and increasing health risk to the recipient.

 

We also note that our microbial analysis of your Solid Ink-Matte Black (Lot (b)(4), FDA Sample #1093540), Solid Ink-White (Lot (b)(4), FDA Sample #1093539), and Solid Ink-Orange (Lot (b)(4), FDA Sample #1093537) products collected intact and unopened at your Miami Gardens, FL facility and your Solid Ink-Olive (Lot (b)(4), FDA Sample #1093550) and Solid Ink-Deep Red (Lot (b)(4), FDA Sample #1093552) products collected intact and unopened from your Austin, TX customer revealed low levels of microbial contamination.

 

We acknowledge that you have recalled your Solid Ink-Diablo product (Lot (b)(4)) due to microbial contamination. FDA recommends you develop a remediation plan to prevent future product contamination.

 

Adulterated Cosmetics:  Insanitary Conditions

 

The tattoo inks that you manufacture are adulterated within the meaning of section 601(c) of the Act [21 U.S.C. § 361(c)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Specifically, during the inspection of your Miami Gardens facility, our investigator documented, based on your statements during the inspection, that the (b)(4)-gallon containers you use to hold your firm's (b)(4) basic color inks which are used to manufacture your finished tattoo inks have not been cleaned in almost (b)(4) years.  New lots of ink are poured in the tanks without proper cleaning.  Lack of cleaning of the (b)(4)-gallon container can lead to growth of microorganisms within the container. Contaminated product which remains in the container could potentially contaminate subsequent batches of the base color, leading to contamination of the finished tattoo ink products.

 

Misbranded Cosmetics

 

FDA has reviewed the product labeling for the samples collected during the inspection of your Miami Gardens facility and from your customer in Austin, TX. Based on our review, we have determined that your Solid Ink-Diablo (Lot (b)(4)), Solid Ink-Matte Black (Lot (b)(4)), Solid Ink-White (Lot (b)(4)), Solid Ink-Orange (Lot (b)(4)), Solid Ink-Olive (Lot (b)(4)), and Solid Ink-Deep Red (Lot (b)(4)) products are misbranded within the meaning of section 602(a) of the Act [21 U.S.C. § 362(a)] 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 these 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 Solid Ink-Olive, Solid Ink-Diablo, and Solid Ink-Deep Red products declare the ingredient "(b)(4)."  The declaration of ingredients must contain the common or usual names of the cosmetic ingredients as required in 21 CFR 701.3(c). The common or usual name for the ingredient "(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.  In addition to these general guidelines, we observed numerous conditions during the inspection of your Miami Gardens facility for which we believe additional controls could help prevent the risk of product contamination, such as the following:
    • Your firm only samples and tests tattoo ink products for the absence of microorganisms or chemical contaminants (b)(4) a year, and you have no written procedures for the collection, analysis, and release of finished tattoo ink products. Establishing and following such written procedures regularly could help prevent contamination with microorganisms such as Clostridium clostridioforme, Clostridium ramosum, and Clostridium sp. Bacillus pumilus and Bacillus megaterium, which were found in your products.
    • Your firm does not perform any testing on any incoming raw materials to ensure the absence of filth, microorganisms, and other adulterants prior to processing or using it in your products. Such testing can help ensure product safety.
    • While you used the multi-functional ingredient alcohol as a preservative in your tattoo inks, your firm failed to evaluate the preservative adequacy of isopropyl alcohol in the products using a microbial test, such as challenge testing. The fact that certain of your products were found to be contaminated with microorganisms suggests that the preservative system used for antimicrobial activity against pathogens was ineffective for your products.
    • You have no established method or standard operating procedures (SOPs) for cleaning and sanitizing the manufacturing area, equipment, and utensils at production start-up, between manufacturing runs, and at the end of production.  Establishing such SOPs could help ensure product safety.
    • Your employee restroom lacks a sign instructing employees to wash their hands after use. Providing effective hand-washing can help prevent the contamination of the tattoo inks, contact surfaces, and packaging materials. 

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 the 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 #587248 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] Alexander CJ et al. 1995. Identification and Antimicrobial Resistance Patterns of Clinical Isolates of Clostridium clostridioforme, Clostridium innocuum, and Clostridium ramosum Compared with Those of Clinical Isolates of Clostridium perfringens. J.Clin.Microbiol. 33;3209-3215.

[2] Williams, OM et al. 2010. A Review of Three Cases of Clostridium Aldenense Bacteriemia. Anaerobe 16:475-477.

[3] Forrester JD & Spain DA. 2014. Clostridium Ramosum Bacteriemia: Case Report and Literature Review. Surg.Infect. 15:343-346.

 
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