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CMP Industries Hit With Warning Letter Over Rust-Like Contamination

October 30, 2015

The FDA has hit Albany, N.Y.-based CMP Industries, a manufacturer of resins for dentures, with a warning letter for not adequately investigating “rust-like specks” found in one of its products, among other violations.

During an April 16 to May 29 inspection, an FDA representative determined the company failed to establish procedures for corrective and preventive action to ensure an adequate investigation of the cause of nonconformities. Specifically, the company removed a certain lot of the Impak Elastic Acrylic Resin Liquid after identifying contamination in the raw material. The company concluded that the root cause was a rust-like material present from decomposition of the drum holding the raw material. However, a CAPA investigation did not review additional lots in similar drums.

Further, the company did not include a review of a complaint involving a lot of the Impak product that maintained there were “rust like specks in 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 letter states.

The letter also chides the company for its CAPA actions, as they weren’t adequate to prevent recurrence of this problem. Although the company had required the supplier of the raw material in question to use new drums with each shipment, CMP was observed reusing emptied drums to manufacture a certain part number of bulk Elastic Acrylic Resin Liquid CMP.

The company also did not conduct a compositional or physical analysis on 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 observations were not adequate, as they do not indicate any actions the company took with respect to the lot of Impak Elastic Acrylic Resin Liquid manufactured with the contaminated raw material that remains in distribution.

“While your response acknowledges the issues noted with your CAPA investigation, CAPA actions and CAPA verification activities and promises some corrections, including revision to your complaint procedures and some manufacturing procedures, no objective evidence was provided to support your statements,” according to the letter.

Quality Systems Issues

In addition, the FDA investigator determined the company failed to establish and maintain procedures to control the design of the device.

“Specifically, you did not implement design control procedures to control the design of your Impak Repair Acrylic Resin Liquid … in order to ensure that specified design requirements are met,” according to the warning letter. In addition, there is no design history file created or maintained.

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, the inspector determined that the company failed to submit a written report of a correction or removal of a device to the FDA, as required by law. It highlights a letter sent to customers in November 2013 asking them to return certain Impak Elastic Acrylic Resin Liquid part numbers in a specific lot.

Upon reviewing the firm’s actions, the FDA determined it should have been notified and that the company’s responses were inadequate. “Your responses do not indicate you would report this medical device correction or removal, or a similar action, in the future,” the letter states, adding that the company hasn’t provided evidence that it has steps in place to prevent a recurrence of this violation.

The company declined to comment on the letter.

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