FDA 483 - Fairy Tales Hair Care Inc. - October 22, 2024

During an FDA inspection conducted from October 9 to October 22, 2024, Fairy Tales Hair Care Inc., an own-label distributor based in Fairfield, NJ, received a Form FDA 483 outlining significant deficiencies in its quality control and operational procedures. The main violations centered on the absence of comprehensive written procedures for critical quality unit responsibilities, including the review and approval of documentation, management of deviations, and the qualification and auditing of Contract Manufacturing Organizations (CMOs). Specifically, the firm failed to conduct annual product reviews for its own-label products and did not adequately qualify its CMOs. Additionally, the inspection revealed shortcomings in the company’s customer complaint handling process, lacking detailed investigation timeframes, proper notification protocols, and effective trending. The procedure for managing retain samples was also found to be deficient, without clear instructions for documented review or examination during complaint investigations. Furthermore, there were no established written procedures or documented records for employee Good Manufacturing Practices (GMP) training or on-the-job training for warehouse personnel. These observations indicate a need for Fairy Tales Hair Care Inc. to implement robust corrective actions, develop detailed standard operating procedures, and enhance employee training to ensure compliance with quality system requirements and the Federal Food, Drug, and Cosmetic Act.