Absonutrix - 508557 - 08/01/2017
August 1, 2017
VIA FEDEX SERVICE
Attention: Lakisha N. Morton
Office of Human and Animal Food Operations - Div. 3 East
60 8th Street NE
Atlanta, GA 30309
Re: Absonutrix LLC (FEI 3012107499) Warning Letter (17-ATL-09) Response
Kindly be advised that Himanshu Nautiyal retained my firm to reply in the matter captioned above. The Warning Letter was received on July 26, 2017. This response is timely.
The firm appreciates your bringing the labeling errors to its attention. It is important to note the website, www.absonutrix.com, is not a point of sale website and no sales occur through the website.
Nevertheless, the firm is committed to full compliance and has removed all the pages statements identified in the notice. The website now fully focuses on the contract manufacturing role central to the firm's operations. The firm believes the corrective actions taken fully satisfy the Agency's concerns and the review will mitigate any further reoccurrence.
Pursuant to the Regulatory Procedures Manual § 4-1-8(2) the firm respectfully requests this response be posted on the Agency's website redacted as deemed necessary.
cc: Himanshu Nautiyal, CEO Absonutrix, LLC