X Spine Systems cited for adulterated devices
Device Regulation Alert: Safety, Compliance and Reimbursement News, August 25, 2008
An FDA inspection found X Spine Systems, Inc., violated Good Manufacturing Practices (GMPs) and as a result, its devices are considered adulterated, according to an FDA warning letter.
The FDA found 12 violations of GMPs, including failure to:
- Identify all actions needed to correct and prevent the recurrence of nonconforming product and other quality problems
- Ensure all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report
- Record the dates and results of complaint investigations
- Establish quality requirements that must be met by suppliers
- Establish procedures that address incomplete, ambiguous, or conflicting design input requirements
The FDA said it was unable to fully evaluate X Spine Systems’ response because the company indicated it was still developing procedures for the proposed corrective actions.
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