FDA Sends Warning Letter to GE
FDA inspectors visiting a GE plant in Ohio documented a number of violations, resulting in a warning letter. The plant manufactures coils used for MRI and breast biopsy plates, both used for diagnostic procedures.
Violations noted by the inspectors include:
- Products were shipped prior to verification or validation;
- Validation procedures, specifically for the breast biopsy plates, were not documented entirely;
- Verification of corrective actions was not completed;
- Records don’t indicate device compliance with master design standards;
- Investigation procedures for device failures are lacking;
- Complaint reponse time is not timely.
The company is working to resolve these issues. Warning letters can result in penalties or product seizures if violations are not addressed.
March 13, 2007 Related topics: Medical Devices & Products, Industry & Market