Color Art, Inc. DBA Solid Ink – FDA Warning Letter, Dec 12, 2018

On September 18, 2019, the FDA issued a Warning Letter to Color Art, Inc. DBA Solid Ink, following an inspection of their tattoo ink manufacturing facility in Miami Gardens, Florida, from December 4-12, 2018. The inspection and subsequent product analysis revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act).

The FDA found that Solid Ink's products are adulterated cosmetics due to microbial contamination. Specifically, Solid Ink-Diablo (Lot (b)(4)) was found to contain significant microbial contamination, including *Clostridium clostridioforme*, *Clostridium ramosum*, *Bacillus pumilus*, and *B. megaterium*. These *Clostridium* species can cause toxin-mediated infections and pose a significant health risk when injected into the skin. Other products, including Solid Ink-Matte Black, Solid Ink-White, Solid Ink-Orange, Solid Ink-Olive, and Solid Ink-Deep Red, also showed low levels of microbial contamination.

The products were also deemed adulterated due to insanitary conditions. The firm's (b)(4)-gallon containers used for basic color inks had not been cleaned in almost (b)(4) years, leading to potential microbial growth and contamination of subsequent batches.

Furthermore, the products were found to be misbranded because they were labeled "sterile" despite containing microorganisms, which is false and misleading.

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