CEO James Stroud received Warning Letter 35-11 in late April. He found that a strict FDA wouldn't consider his response to an inspector's Form 483 observations because the response was late--beyond the 15-day deadline after the report is issued. The response deadline came into effect after FDA Commissioner Hamburg promised stricter measures to enforce GMP compliance. It's now a regular feature of 483 reports and warning letters.
"We acknowledge your written response to the Form FDA 483," the warning letter says. "However, because this response was received more than 15 business days after the Form FDA 483 was issued, the response has not been considered. We plan to evaluate your response to the Form FDA 483, along with any other written material provided, as a direct response to this Warning Letter."
Inspection of the Camarillo, CA, plant took place from mid-January to early February of this year. It was a follow-up visit to a December 2010 inspection. Among the 5 violations cited in the warning is a failure to investigate deviations during a product review. "This is a repeat observation from the December 15, 2010, inspection," the letter says.