FDA 483 - Puremedy Inc. - July 26, 2024

Puremedy Inc. received an FDA Form 483 following an inspection from July 15 to July 26, 2024, identifying significant deviations from Good Manufacturing Practices (GMP) for its homeopathic drug products. The primary observations highlighted systemic failures in production, quality, laboratory, material, equipment, and labeling control systems, many of which were repeat observations from previous inspections. Key issues included the absence of written procedures for production and process controls, lacking process validation, and incomplete batch records that did not capture critical manufacturing parameters like temperature, mixing speed, or duration. The firm also lacked defined responsibilities and procedures for its quality control unit, failing to establish processes for approving raw materials, investigating deviations, or testing materials to specifications. Furthermore, Puremedy did not test finished drug products for active ingredient assay or microbial contamination and had no stability data to support product shelf-life. Other deficiencies involved not verifying raw material identity, failing to calibrate electronic equipment, not qualifying manufacturing equipment, and insufficient control over drug product labeling. To ensure compliance with regulatory standards, Puremedy Inc. must address these observations by implementing robust quality systems, validating processes, establishing comprehensive testing protocols, and ensuring proper equipment management and labeling controls.