Hardball warning to Claris defines CMO role

The mysterious and insightful columnist known only as QA Pharm ponders the FDA's intent in the Claris swirling-mass warning letter. The warning may be an indication of the regulator's ongoing interest in contract manufacturers. But it also could be an example of its current emphasis on brand-holder responsibility in CMO relationships.

By way of support, he cites the inclusion of partner names in the publicly posted warning. Both Pfizer and Sagent Pharmaceuticals are identified, arguably raising the letter's visibility. Not to mention the strain it must place on Claris's relationship with them.

QA Pharm also notes that the warning letter's concise direction for the detail the FDA expects in the company's reply: "...include your final investigation, assessment, rational[e] and the corrective actions implemented addressing your failure to initiate the complaint investigation promptly," and "...provide specific information regarding the requalification of the printing operation, and any formal study conducted to demonstrate the new printing parameters that the response states your firm adopted will prevent recurrence of the problem."

- see the column
- here's Warning Letter 320-11-003

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