FDA 483 - Robinson Pharma Inc - August 30, 2017

Robinson Pharma Inc, a dietary supplement manufacturer in Santa Ana, CA, was inspected by the FDA from August 24-30, 2017. The inspection revealed that the firm's quality control operations failed to review and approve all batch production-related records. Specifically, products were shipped to customers before final Certificates of Analysis were generated and before all batch records were reviewed and signed for release.