FDA 483 - Robinson Pharma Inc - September 25, 2014

An FDA inspection conducted at Robinson Pharma Inc., a dietary supplement manufacturer located in Santa Ana, CA, between September 12 and September 25, 2014, revealed significant deficiencies in its quality control operations. The inspection, summarized in an FDA Form 483, highlighted three primary issues.

Firstly, the company failed to ensure that each finished product batch conformed to established specifications before distribution. Specifically, complete batch record reviews were not performed, and finished product testing was frequently completed only after the products had already been shipped to customers, thereby not influencing the release decision.

Secondly, Robinson Pharma Inc. lacked adequate documentation to demonstrate that its selected specifications for product identity, purity, strength, and composition were sufficient to guarantee finished product quality. The firm relied on a "Confirmed By Manufacturing Practices" (CBMP) method for Certificates of Analysis, which involved no actual analytical testing. This practice, along with a failure to follow its own standard operating procedures for finished product testing, meant that many ingredients declared on product labels were not adequately verified.

Finally, the company's quality control procedures did not consistently include the proper approval and release or rejection of finished batches for distribution. Instances were noted where finished products were shipped without the required batch record review sign-offs. Robinson Pharma Inc. is required to address these observations with robust corrective actions to ensure compliance with dietary supplement manufacturing regulations.