FDA 483 - Chameleon Beverage Co Inc - April 02, 2021

During an FDA inspection conducted from March 29 to April 2, 2021, an OTC drug repacker located in Commerce, CA, received a Form FDA 483 detailing seven significant observations. The issues primarily highlight critical deficiencies in adherence to current manufacturing practice regulations for drug products.

Key violations include a lack of established written specifications and analytical testing for both incoming bulk and finished gel hand sanitizer drug products, indicating insufficient quality control over product identity, strength, and purity. The firm's quality control unit also lacked formally written responsibilities and procedures, failing to maintain reserve samples or adequate documentation for sampling, testing, and manual filling operations. Equipment used for filling was found to be unsuitable for its intended use, lacking proper cleaning procedures and records. Furthermore, the company failed to prepare comprehensive batch production and control records for numerous products and maintained incomplete distribution records, missing essential details like drug product names, 'Best By' dates, consignee information, and lot numbers. Finally, written procedures for the control, issuance, and reconciliation of labeling were absent.

These observations indicate a systemic need for the firm to implement robust corrective actions to bring its operations into compliance with regulatory standards.