FDA WARNING_LETTER - Synbiotics Ltd - August 27, 2010

On August 23, 2010, the FDA attempted an inspection of Synbiotics Limited's API manufacturing facility in Vadodara, India, but was denied full access, being restricted to a business office. Information and limited documents reviewed during August 23-27, 2010, revealed significant deviations from Current Good Manufacturing Practice (CGMP) for APIs, rendering their products adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

The firm's September 1, 2010, response was deemed insufficient. Key violations included: 1. **Failure to prepare, review, and approve essential manufacturing documents:** At the time of shipping a specific API lot to the U.S. in January 2010, no procedures existed for change control, out-of-specification investigations, process deviation investigations, laboratory incidents, consumer complaint handling, or annual product reviews. The firm acknowledged its quality system was "inadequate" and "critical Quality Assurance functions were missing." 2. **Failure of the quality system to ensure consistent product quality:** The firm had not performed validation of the manufacturing process for the shipped API lot, nor established a process design, validation plan, or qualification protocols. The FDA disagreed with the firm's assertion that meeting USP requirements alone ensured safety, given the lack of process validation and an inadequate quality system.

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