Alphatec reveals FDA warning letter

Alphatec (NSDQ:ATEC) yesterday revealed that it received a warning letter from the FDA over problems at a plant in it home base of Carlsbad, Calif.

The July 16 warning letter cites 8 “deficiencies” in Alphatec’s response to the FDA’s initial observations after it inspected the plant in February and March, the company said.

“The deficiencies relate to the company’s internal procedures for quality planning, design control, document control and corrective and preventive actions,” Alphatec said.

Alphatec’s spinal implants can still be sold in the U.S. despite the letter, the company said, noting that it’s addressing the deficiencies and “intends to work closely with the FDA to resolve any outstanding issues.”

The FDA hasn’t yet posted the warning letter, Alphatec said.

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