The FDA inspected the company’s Plano, Texas manufacturing facility at various times between March 5 and April 6, 2009. On April 6, 2009, the FDA issued a Form 483 identifying certain observed non-conformities with Current Good Manufacturing Practice. Following the receipt of the Form 483, the company’s Neuromodulation division provided written responses to the FDA detailing proposed corrective actions and immediately initiated efforts to address FDA’s observations of non-conformity. The FDA warning letter acknowledges actions already taken by the Company to address the observations.
The FDA letter notes that it will not grant requests for exportation certificates to foreign governments or approve pre-market approval applications for Class III devices to which the quality system regulation deviations are reasonably related until the violations have been corrected.
Customer orders are not expected to be impacted while we work to resolve the FDA’s concerns. The Company takes these matters seriously and has already begun to respond timely and fully to the FDA’s requests, and believes that the FDA’s concerns can be resolved without a material impact on the company’s financial results.
