Medical printing vendor Codonics said it is working with the Food and Drug Administration to resolve a warning letter issued following an August inspection at the Middleburg Heights, OH-based vendor.
From the inspection, the FDA indicated in an October 2 warning letter that Codonics was not in conformance with the requirements of the Quality System Regulation (QSR) of the Code of Federal Regulations due to:
- Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained.
- Failure to conduct quality audits on a periodic basis in accordance with written procedures.
- Failure to establish and maintain an adequate corrective and preventive action (CAPA) plan.
- Failure to establish and implement an adequate complaint-handling program.
- Failure to establish and maintain procedures designed to control device design in order to ensure that the specified design requirements are met.
- Failure to ensure that only current and approved versions of documents are used in design and manufacturing of medical devices.
- Failure to establish and maintain procedures to ensure that device-history records (DHRs) for each batch, lot, or unit are maintained in order to demonstrate that medical devices are manufactured in accordance with the device master record and the QSR.
In addition, the FDA determined that Codonics' medical devices were misbranded. Specifically, the agency found that Codonics failed to develop and maintain written Medical Device Reporting (MDR) procedures, according to the warning letter.
Unfortunately, the FDA's audit took place when the firm was in transition from its existing initial quality system to a new "overarching" system, Codonics director of quality assurance and post-sales support Roderick Dayton told AuntMinnie.com.
"As a result of the discontinuity between the old and new systems documentation, and significant deficiencies in the early systems documentation, the FDA audit resulted in a warning letter being issued," he said.
Codonics accepted the FDA's findings as constructive and necessary, Dayton said. The issues raised by the FDA were primarily related to documentation that ties all of the firm's existing systems together, he said. Since then, the firm has released its quality manual and quality procedures manual, documents that incorporate these items, Codonics said.
"Because Codonics was already in transition to a significantly improved system, the company was able to respond quickly to the FDA’s request with documentation and a continuing action plan to assure that the new system is fully established," he said.
The firm believes its responses will be satisfactory to the FDA, and that the agency's actions have not compromised Codonics' ability to produce or ship products.
By AuntMinnie.com staff writersNovember 4, 2002
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