Alphatec Holdings Inc. (NSDQ:ATEC) said it’s resolved the issues flagged in a warning letter it got from the FDA last year.
The Carlsbad, Calif.-based firm, the holding company for Alphatec Spine, received the letter in June 2010 after the FDA inspected a plant the Golden State. The letter cited inadequate design validation, corrective and preventive and complaint review procedures at the facility.
Alphatec said a close-out letter dated Sept. 28 from the federal watchdog agency "stated that the company has resolved all the deficiencies contained in the warning letter," according to a press release.
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"The successful resolution of the Warning Letter demonstrates our firm commitment to maintaining a robust quality system throughout our organization," president & CEO Dirk Kuyper said in prepared remarks.
In July Alphatec defended partner Parcell Laboratories after the FDA said the PureGen stem cell-based bone regeneration product it co-developed with Parcell was mis-categorized as a human cell, tissue, and cellular or tissue-based product.
The FDA alleged that the product doesn’t meet all of the criteria for that classification and that PureGen should be regulated as a drug under the Federal Food, Drug & Cosmetic Act and as a biologic under the Public Health & Welfare Act. That means Parcell must produce either a biologics license or a sponsor must have an investigational new drug application in effect in order for PureGen to continue development, according to the agency.
“Both Alphatec Spine and Parcell Laboratories are fully committed to work closely and collaboratively with the FDA to address the questions related to the PureGen product. We look forward to discussing the PureGen product with the FDA and sharing our clinical outcomes to date,” Kuyper said at the time.
