"Inadequates" in Gilead response led to FDA warning

The QA Pharm columnist counts the word "inadequate" 18 times in the FDA's warning letter to Gilead.  The warning details inadequacies in the drugmaker's response to a Form 483 report following an inspection of the company's San Dimas, CA, plant.

The inadequacies concern rationales, justifications, and timeframes, as well as details for proposed fixes, appearing in the response, according to the column, which appears in PharmaPro. Added up, the inadequacies yielded Warning Letter W/L 44-10.

The columnist goes beyond scolding to summarize the regulator's suggestions for writing an effective response. Among the eight items: Tell the FDA your plans for corrective actions. "Be specific, be complete, be realistic, and be able to deliver what you promise," according to the column.

One common pitfall identified by QA Pharm concerns contributions from various levels of management and the legal department, which result in seven characteristic shortcomings in responses. The proof of QA Pharm's characteristics list is readily apparent in any review of warning letters, simply by following the "inadequates."

- here's the column