The FDA warned Alphatec ATEC in a letter in response to 483 letter issued during an inspection at Alphatec's Carlsbad, CA manufacturing facility.
Alphatec stressed that the letter focused on control and procedures, not product defects.
Jefferies does not believe this will impact business, but might affect FDA approvals. Alphatec is currently in discussions on the approval of its Solus drug. Jefferies said, "Whether the warning letter will impact the timing or outcome of these discussions remains an open issue."
ATEC is currently rated Buy, with a price target of $8.00. Shares are currently trading at $4.40.
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