Alphatec Holdings Inc (ATEC)

[bacc]

Alphatec Spine Announces Successful Resolution of FDA Warning Letter
print
Alphatec Holdings, Inc. (MM) (NASDAQ:ATEC)
Intraday Stock Chart
Today : Wednesday 5 October 2011

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced today that it has resolved a Warning Letter that it had previously received from the U.S. Food and Drug Administration for the Company's Carlsbad, CA, facility.



The FDA issued the Warning Letter on June 21, 2010 in connection with deficiencies in the response letter sent by the Company to the FDA in connection with a FDA inspection that occurred in February 2010.



Subsequent to a follow-up audit of the Company's facility, the FDA issued a close-out letter dated September 28, 2011. In this letter, the FDA stated that the Company has resolved all the deficiencies contained in the Warning Letter.



"The successful resolution of the Warning Letter demonstrates our firm commitment to maintaining a robust quality system throughout our organization," said Dirk Kuyper the Company's President and CEO.