FDA 483 - Dermya, Inc. - June 05, 2019

Permya, Inc. dba Kidskin, a repacker/relabeler in Valley Village, CA, was cited for significant deficiencies in its quality control unit and laboratory controls. The inspection revealed a pervasive lack of written procedures for critical operations such as product testing, complaint handling, stability assessment, and equipment maintenance. Additionally, the firm lacked written specifications for drug product components and quality agreements with contract manufacturers for its Kidskin Daily Sunscreen SPF 30 product.