Codonics does not adequately address unvalidated CAPA, FDA. (Medical Devices).

Medical printer manufacturer Codonics' Aug. 27 response to FDA promising corrective actions on its Quality Systems regulations was not adequate, the agency stated in an Oct. 2 warning letter to the Middleburg Heights, OH, firm.

According to the just-released letter, the firm's "preliminary procedure for Corrective and Preventive Action does not address validating the corrective and preventive actions to ensure that such actions are effective and do not adversely affect the finished device."

The manufacturer of medical image printers was also cited for not approving or implementing procedures from the firm's quality manual, the letter stated.

FDA continued that Codonics had conducted only one internal quality audit on Dec. 12, 2001, in the six years it had been making the devices.

Other deficiencies included the lack of a complaint handling program, design controls, or procedures to ensure that device history records are maintained.

Additionally, the agency cited the firm for failing to develop written Medical Device Reporting (MDR) procedures.

Codonics Director of Quality Assurance Roderick Dayton said in a telephone interview that "the audit occurred while the company was in transition from its existing initial quality system to a new overarching system." Dayton added that the transition did not compromise product integrity at the time.

Dayton said his company responded satisfactorily to FDA, adding that the firm has been implementing an ISO 13485 system in addition to "the points raised by the FDA [to] help us ensure that our actions provide the proper coverage of functional disciplines."

The investigator who handled the Aug. 21-27 audit for the Cincinnati district was not identified in the letter. Doc. 11950W