The letter said the agency will not grant requests for export certificates to foreign governments or approve premarket approval applications for Class III devices to which the quality system regulation deviations are reasonably related until the violations have been corrected, according to the company.
The FDA-483 cited 11 inspectional observations covering process validation, design verification, design validation, design change, design history file, training, corrective and preventive actions (CAPA) system, CAPA procedures, complaint files, document control, and control of inspection, measuring, and test equipment. The observations are related to the firm’s troubled Durata ICD leads.
The agency also released the company’s November 7 response with binders containing its completed and planned actions for each of the observations. St. Jude reported that in addition to the steps noted in the binders, it was preforming the following actions:
- Providing additional learning activities to ensure enhancement of its staff’s knowledge regarding the quality system elements.
- Identifying and implementing improvements to ensure robust processes for the design and development of products and processes.
- Identifying and implementing improvements to the CAPA and risk management processes to enhance monitoring and control of the overall quality system.
In a statement, St. Jude said the Warning Letter did not “identify any specific concerns regarding the performance of, or indicate the need for any field or other action regarding the Riata ST Optim or Durata leads or any other St. Jude Medical product.” The company said it would continue manufacturing and shipping product from the Sylmar facility and customer orders were not expected to be impacted while they worked to resolve FDA’s concerns.
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