FDA 483 - Dermya, Inc. - June 05, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 57d08183-7b3c-4e25-9a85-bc761033aadf