FDA 483 - Alfa Vitamins Laboratories Inc. - July 17, 2024

During an inspection conducted from July 9-17, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Alfa Vitamins Laboratories Inc., a dietary supplement manufacturer located in Miami, FL. The inspection revealed eight significant observations, indicating deficiencies in the company's adherence to regulatory requirements for manufacturing and quality control.

Key issues included a failure to maintain appropriate storage conditions for components and finished products, with multiple humidity deviations not properly addressed or documented—a repeat observation from a previous inspection. The company also failed to follow its written laboratory procedures for monitoring refrigerator temperatures for microbiology media and lacked proper quality unit review of these records, also a repeat finding.

Further observations involved inadequate hand-washing facilities lacking suitable water temperature and soap, and the improper storage and identification of cleaning agents, posing a contamination risk. Alfa Vitamins was cited for deficiencies in its documentation practices, specifically for master manufacturing records that omitted representative labels and for not having approved master manufacturing records for packaging operations. Critically, the company failed to establish clear product and component specifications for strength and composition, instead relying on vague "Report Results" or "As per Vendor Specification" without defined limits.

These observations highlight the need for Alfa Vitamins Laboratories Inc. to implement comprehensive corrective actions to ensure compliance with current Good Manufacturing Practices (cGMP) for dietary supplements and prevent recurrence of these issues.