Design, Process Validation Lead to Warning for Acme

Acme Monaco received an FDA warning letter for failures related to design validation, process validation and other GMP issues.

According to the April 28 letter posted recently online, the company did not validate the design of its polytetrafluoroethylene-coated guidewires under actual or simulated conditions for use. Further, its risk analysis is inadequate because it doesn’t assess flaking and delaminating of the coating during use.

The New Britain, Conn., company, which makes guidewires for cardiovascular and urologic use, also lacks procedures to control changes to the device design, the letter says. Acme changed the formulation of the PTFE coating material “without any evaluation of validation, verification, review or approval prior to implementation of the change.”

According to the letter, Acme did not validate the following processes:

• Cleaning of finished medical guidewires before coating using the Ultra Kool vapor immersion type solvent-based degreasing unit;
• Post-coating of guidewires it contracts to outside vendors; and
• Solvent-based cleaning of precoated guidewires using equipment designed and built by the company.

Corrective action slips also drew FDA scrutiny. The company did not implement identified corrective actions in response to a complaint about PTFE coating flaking during use. “You identified the need for an acceptance test to assess coating integrity for incoming coated guide wires received from outside vendors on 8/7/13, but did not implement action prior to shipping product from lot 056066-1-1A on 8/23/13 or lot 056066-1-1B on 10/3/13,” the letter says.

The company also failed to adequately investigate nonconforming product so it could identify all appropriate corrective actions.

For example, Acme identified nonconforming product in the inventory of one lot of guidewires that had been shipped. Out of 1,680 guidewires, 1,010 failed wet abrasion and tape tests for flaking coating and bent or bridging parts. But the investigation did not include a risk assessment to identify any health hazard associated with the distributed units, which did not undergo acceptance testing for coating integrity.

Acme did not respond to a request for comment by press time.

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