Vitalabs, Inc. – FDA EIR, Dec 19, 2018

An FDA inspection of Vitalabs, Inc., a dietary supplement repackager and labeler, was conducted from December 12-19, 2018. This comprehensive review operated under the Food Safety Modernization Act (FSMA) and specific compliance programs for dietary supplements and food safety. While no formal FDA Form 483 was issued, the inspection revealed numerous significant concerns regarding the firm's operations.Key issues included improper storage of allergen-containing ingredients, unsecured hazardous material storage, and critical failures in manufacturing data integrity. Equipment operational performance and qualification records were absent, and the facility lacked a sufficient number of adequately located handwashing stations. Procedural deficiencies were noted in cleaning processes (failing to distinguish major/minor equipment) and employee training requirements for specific roles. Furthermore, the Quality Control unit did not review contract manufacturer Batch Production Records, and recall procedures lacked provisions for corrective actions when specifications were not met. The manufacturing area was deemed inadequately sized, and production runs were not designed to prevent batch mix-ups, with essential sanitation and environmental records missing from Master Batch Records.Vitalabs' management exhibited full cooperation, committing to address all identified concerns. Proposed actions include implementing procedural updates, enhancing data security, conducting equipment qualifications, installing additional handwashing stations, revising training programs, expanding the manufacturing facility, and integrating all necessary records into batch documentation, with target completion dates throughout 2019.