Warning Letter for OTC Acne & Sunscreen Manufacturer

The US Food and Drug Administration has issued a warning letter to The Skin Atelier, Inc., d.b.a. Skinprint, Goshen, NY, following an inspection conducted from March 28 to April 4, 2019. The agency said it found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, including acne treatments and sunscreens including: Spot-On with 5% Micro-Benz Benzoyl Peroixde  Spot Treatment, Reflect SPF 50 Broad Spectrum Sunscreen and Blemish Control Cleanser 2% Salicylic Acid. 

According to FDA, Spot-On with 5% Micro-Benz Benzoyl Peroixde Spot Treatment is an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). FDA also noted that Reflect SPF 50 Broad Spectrum Sunscreen”and Blemish Control Cleanser 2% Salicylic Acid are misbranded drugs under section 502(c) of the FD&C Act, 21 U.S.C. 352(c). 

According to FDA, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

The agency noted that The Skin Atelier's finished drug product release testing was inadequate for multiple over-the-counter (OTC) topical drug products, including but not limited to Ultra Sheer SPF20, Reflect SPF50, and Blemish control cleaner. It said the firm lacked identity and strength testing for each active ingredient as part of the finished drug product release testing;  lacked validation or verification to determine adequacy of the microbial test kit and methods used for microbiological release testing of finished drug products; and lacked testing for objectionable microorganisms.

FDA also alledges that The Skin Atelier's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

FDA said the The Skin Atelier's QU failed to ensure adequate procedures and did not provide adequate oversight of manufacturing activities. For example, the firm lacked many important quality and production procedures, including appropriate provisions for batch review/disposition, deviations, out-of-specification results, investigations, complaints, recalls, change controls, annual product reviews, equipment qualification, method validation/verification, and controls for issuance, handling, reconciliation, and storage of OTC drug product labeling.

FDA said the company’s review of batch records was inadequate and that its supplier qualification was inadequate. According to FDA, the company accepted incoming components, such as titanium dioxide, zinc oxide, and salicylic acid, from suppliers solely based on certificates of analysis. The firm’s QU failed to ensure the suitability of all incoming lots of components for use in drug product manufacturing.

This violation is a repeat violation fromThe Skin Atelier’s last inspection in 2006, said FDA. 

FDA also said the company failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

The FDA said Skinprint also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. 

The full letter can be accessed here.