FDA WARNING_LETTER - The Skin Atelier, Inc. d.b.a. Skinprint - April 04, 2019

The FDA issued a Warning Letter to The Skin Atelier, Inc., d.b.a. Skinprint, following an inspection from March 28 to April 4, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Finished Drug Product Release Testing (21 CFR 211.165(a)):** The firm failed to perform identity and strength testing for active ingredients and lacked validation for microbial testing, including for objectionable microorganisms, on products like Ultra Sheer SPF20, Reflect SPF50, and Blemish Control Cleanser. 2. **Failure of Quality Control Unit (21 CFR 211.22):** The Quality Unit (QU) was inadequate, lacking essential procedures (e.g., batch review, deviations, OOS, complaints, change control, annual product reviews, equipment qualification, method validation, labeling controls). Batch record review was insufficient, master batch records were not QU-approved, and supplier qualification was inadequate, accepting components solely based on Certificates of Analysis. This was a repeat violation from a 2006 inspection. 3. **Inadequate Stability Program (21 CFR 211.166(a)):** The firm lacked a robust stability program, setting unsupported expiration dates, not monitoring active ingredients or degradation products, and failing to continuously monitor stability chamber conditions