FDA 483 - Sombra Cosmetics, Inc - July 26, 2024

Sombra Cosmetics, Inc. was issued an FDA Form 483 following an inspection from July 15-26, 2024, identifying multiple significant deviations from current Good Manufacturing Practices (cGMP). The inspection revealed widespread issues with the company's quality control unit, which failed to adhere to written procedures for equipment qualification, process validation, cleaning validation, and vendor qualification. Specifically, the firm lacked documentation for purified water systems, stability testing rooms, and critical process validations for various drug products. Additionally, Sombra Cosmetics failed to adequately monitor its purified water systems, investigate customer complaints thoroughly (lacking root cause analysis or extended investigations), and conduct annual product reviews. Deficiencies also included inadequate identity testing for incoming drug components, absence of critical testing for contaminants like Diethylene Glycol, Ethylene Glycol, and methanol in finished products, and no testing for Burkholderia Cepacia. The firm lacked validated test methods and a robust stability testing program to support the three-year expiration dates for its drug products. To achieve regulatory compliance, Sombra Cosmetics, Inc. must promptly implement comprehensive corrective actions to address these fundamental gaps in its quality system, validation efforts, testing protocols, and documentation.