FDA 483 - FloSpine, LLC - November 18, 2022

FloSpine, LLC, a medical device manufacturer based in Boca Raton, FL, underwent an FDA inspection from November 14 to November 18, 2022. The inspection resulted in the issuance of a Form FDA 483, detailing two significant observations related to the company's quality system requirements.

The primary issue identified was an inadequate investigation of complaints. Specifically, Complaint #22-01, concerning a Panama Cervical Plate system failure where the locking cover plate protruded and rotated, was not thoroughly investigated. The investigation failed to connect this incident to a previous non-conformance report (NCMR #027) for similar issues from the same product lot, nor did it adequately consider internal engineering test results that showed significantly lower ultimate loads for locking cover plates from the implicated lot. This highlights a deficiency in addressing root causes and ensuring product integrity.

The second observation noted FloSpine’s failure to adequately evaluate potential suppliers. The firm did not ensure its new Panama Cervical Plate supplier could meet specified requirements prior to entering into a purchase agreement. This oversight immediately led to product quality issues, as evidenced by NCMR #027, where two units from the first supplied lot failed acceptance due to cover plate rotation. Subsequent non-conformance reports (NCMRs 29, 30, 31) for issues related to cover plate swaging from the same supplier further demonstrated this systemic failure in supplier qualification.

FloSpine, LLC "promised to correct" both observations, indicating the need for immediate corrective actions to ensure compliance with medical device quality system regulations. This includes strengthening complaint investigation processes and implementing robust supplier evaluation protocols to safeguard device safety and effectiveness.