FDA EIR - VitaPros - January 12, 2024

An FDA inspection of VitaPros, a dietary supplement manufacturer located in Maple Grove, MN, was conducted from January 9-12, 2024. This comprehensive, unannounced inspection assessed the firm's compliance with current Good Manufacturing Practices (GMPs) for dietary supplements, as outlined in 21 CFR Part 111. The inspection identified significant deficiencies, leading to the issuance of an FDA Form 483 with four observations and six additional verbal observations. Primary issues included a lack of robust quality control operations, specifically concerning the approval of finished product specifications and documented review of testing results before product release. The company failed to ensure that testing methods for specifications were scientifically valid and appropriate. Inadequate cleaning and sanitation procedures for manufacturing equipment and utensils were noted, alongside a failure to assess established contamination limits for finished products. Additional concerns raised verbally covered deficiencies in laboratory control processes for reference materials, infrequent re-confirmation of supplier Certificates of Analysis, and incomplete batch production records lacking proper label reconciliation, representative labels, or verification of component weights. Furthermore, the firm's expiration dates for some products were not supported by valid data. VitaPros management acknowledged the observations and discussed immediate and planned corrective actions, committing to provide a formal electronic response to the FDA Form 483 outlining these measures to address the identified non-compliance issues.