Tuesday, April 08, 2014 1:43:07 PM
This letter is not intended to be an all-inclusive list of violations in your products. It is your responsibility to ensure all of your products comply with the Act and other applicable regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction.
(b)(4)
You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to: Ms. Kimberly Dutzek, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact Ms. Dutzek at (615) 366-7826.
This will be corrected and the stock will go up in no time. People are mad to sell at this moment. When it moves up they miss their changes to make money here.
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