Still there. Here is some wording from the letter. Funny how we never hear about the harshness of the wording from the FDA. Love the QC expertise here.
During the inspection, we determined that you submitted approximately half of your 15-day Alert Reports late (b)(4). Additionally, for abbreviated new drug applications (ANDAs) 076723 and 202248, you incorrectly submitted PADERs late, without a descriptive section, on the wrong reporting schedules
Your firm's written response is inadequate because you failed to assess the root causes and impact of the observations. You also failed to describe how you will monitor and review your actions to ensure effectiveness and prevent recurrence
In addition, we are concerned about your firm's fundamental understanding and implementation of PADE regulations, including how they relate to your use of contractors. As the application holder of 11 ANDAs, you are ultimately responsible for ensuring compliance with the Act and PADE regulations. The lack of adequate written procedures observed during the inspection and examples of failure to report safety information to FDA in a complete, accurate, and timely manner raises concerns about your firm's ability to assess the safety of your drug products.
The FDA's response to Elite's first response letter was just short of scathing. From the FDA:
As the application holder of 11 ANDAs, you are ultimately responsible for ensuring compliance with the Act and PADE regulations. The lack of adequate written procedures observed during the inspection and examples of failure to report safety information to FDA in a complete, accurate, and timely manner raises concerns about your firm's ability to assess the safety of your drug products
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