Letter to FDA Regarding Outbreak of Fungal Meningitis
Excerpt: During initial discussions with committee staff on October 12, 2012, FDA officials said that the NECC responded about a month after the warning letter assuring regulators that the firm was in compliance with good compounding practices. At the time of this briefing, FDA officials could not confirm whether any subsequent inspections were conducted to validate that the FDCA violations were corrected. During the briefing, FDA committed to providing the committee with additional details regarding past interactions with the NECC.
To read the letter, click here.
To read a related press release, click here.