Rust-Like Contamination Brings Warning to Dental Company
The FDA hit Albany, N.Y., devicemaker CMP Industries with a warning letter for numerous GMP violations, including not adequately investigating rust-like particles in one of its products.
During an April 16 to May 29 inspection, an investigator found that CMP had failed to establish procedures for corrective and preventive actions to ensure adequate investigation of nonconformities. Specifically, the firm removed a lot of Impak Elastic Acrylic Resin Liquid after determining the raw material was contaminated by rust from the drum in which it was stored, but didn’t review additional lots in similar drums.
CMP also failed to include a review of a complaint regarding rust-like specks in the Impak liquid to see if the problem was related to the issue being investigated. “Your firm concluded this complaint was a result of fiber-like material contamination without any compositional or physical testing to support the complaint conclusion,” the warning letter states.
The letter also chides CMP’s CAPA actions, saying they wouldn’t prevent recurrence of this problem. While the firm required its raw material supplier to use new drums with each shipment, it reused emptied drums to manufacture a certain part number of bulk Elastic Acrylic Resin Liquid CMP.
The letter also takes the company to task for not conducting a compositional or physical analysis of incoming shipments packaged in new drums to verify that the corrective action had eliminated rust-like materials.
According to the FDA, CMP’s June 5 and 30 responses to the 483 were inadequate, as they don’t indicate any actions taken to address Impak Elastic Acrylic Resin Liquid manufactured with the contaminated raw material that remains in distribution.
Quality System Issues
CMP also failed to establish and maintain procedures to control the design of the device and had no design history file for the Impak device.
In a June 5 response to the 483, the company said it was not aware that the design history file was incomplete and that it will make a retrospective one in the next 30 days. The FDA has determined that the design file remains incomplete for the product.
Finally, CMP failed to submit a written report of a correction or removal of a device to the FDA, as required by law. The warning letter cites a November 2013 letter asking customers to return certain Impak Elastic Acrylic Resin Liquid parts in a specific lot.