Golden State Medical Supply CEO James Stroud found himself the recipient of a howler in late April. Whether he's a fan of the Harry Potter series and knows of the magical letter that begins yelling when opened, there's no mistaking the FDA's intent in Warning Letter 35-11.
The letter details several manufacturing violations, but it is perhaps most distinguished by two elements. First is the agency's refusal to consider comments made by the company in response to the FDA inspector's findings. The comments were late--"received more then [sic] 15 business days after the Form FDA 483 was issued," the warning letter says, without revealing whether it couldn't or wouldn't consider the late submission.
The point may be noteworthy given the timeline. The inspection occurred between Jan. 19 and Feb. 2; the company response letter date was Feb. 25, while the warning letter date was April 26. That's 17 business days between the company's receipt of the Form 483, assuming it was issued on the last day of the inspection; 16 days if you exclude President's Day, Feb. 21.
So the matter boils down to one business day over a process that spans 27.
But, rules are rules. And that brings us to the second distinguishing characteristic of this warning, an admonition concerning the company's failure to investigate deviations during a product review: "This is a repeat observation from the December 15, 2010 inspection."
Now the late letter is cast in a different light, compared with the company's apparent inaction to a violation cited nearly 20 weeks earlier.
- see Warning Letter 35-11
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