After conducting an inspection of Abbott Laboratories’ manufacturing plant in March, the FDA issued a warning letter to the company’s Diabetes Care unit upon finding multiple manufacturing violations surrounding its FreeStyle and Navigator glucose monitoring systems.
In the July 2 letter, the FDA said that aspects of the products’ manufacturing, storage or installation at Abbott's Alameda, Calif., plant breached aspects of the Current Good Manufacturing Practice requirements of the quality system regulation.
The FDA reported that the company failed to:
- Adequately test and inspect the products for quality testing purposes;
- Perform corrective action or effectiveness checks for violations surrounding empty blister packages produced on the Noack Blister Packer or scratches to its FreeStyle Lite strips. The FDA said that Abbott did not provide evidence of corrective action for these problems;
- Properly validate the device design for the Navigator system and follow the proper procedures for the validation; and
- Hire staff that possessed the necessary skills or qualifications to ensure that the aforementioned procedures for proper testing and manufacturing of the systems were correctly performed.
“Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice,” the letter stated
The FDA has granted Abbott 15 days to notify the agency of the corrective actions taken and an explanation of how the violations listed will be prevented in the future.