Fisher & Paykel Healthcare, Irvine, CA, Feb. 2 (Irvine, CA).(MEDICAL DEVICES)

An Oct. 25-Dec. 6, 2006 inspection found that the assembler of radiant infant warmers and neo-natal accessory products were not in conformance with current GMP requirements of the QS regulations for medical devices.

For example, the firm failed to establish, maintain and control written procedures for the handling of complaints and to conduct proper evaluations to determine whether or not the reported problems required reporting via the Medical Device Reporting (MDR) process.

Specifically, the investigation disclosed that the firm did not forward all necessary and relevant information regarding evaluations of complaints to the principal manufacturing site.

The investigation disclosed five instances of malfunctions not documented as complaints. Also, FDA found numerous instances of information reported from field representatives involving problems with devices not being made part of their respective complaint files.

In addition, the company did not establish, implement and control adequate procedures for implementing CAPAs.

Specifically, FDA found that all the necessary activities needed to correct and prevent recurrences of non-conforming product and other quality problems, such as, repairs, upgrades and/or testing to ensure conformance to original design were not documented.

The letter also stated that all necessary information related to quality problems or nonconforming product was not disseminated to those directly responsible or assuring the quality or preventing the problems.

Also, the warning letter cited the company because of failure to establish, implement and control procedures for performing and verifying servicing conducted and verifying that servicing meets the specified requirements.

Specifically, disclosed service reports did not describe the work performed, procedures used, or the method and equipment used to service and repair devices.

The agency further noted failure to ensure that all personnel were trained to adequately perform their assigned responsibilities and that the training was documented.

For example, the company had no formal documented training program that ensured that employees were trained on the job.

FDA acknowledge the firm's written response dated Dec. 22, 2006, that indicated the firm's Quality System Plan included a comprehensive approach to assessing and improving all of the components of its quality system, including training of employees.

Also noted was failure to establish, implement and control written procedures for the assembly and/or installation of devices to ensure conformance to specifications.

Specifically, FDA found that the firm was assembling the CosyCot Radiant Infant Warmer and accessory devices in a parking lot and that there was no documentation describing the assembly, installation, measurement and test equipment used, and tests conducted to ensure that the device conforms to its specifications.

FDA acknowledged the firm's Dec. 12, 2006 response that indicated the firm stopped assembly operations on Nov. 13, 2006. That response further stated that assembly of these devices may resume after the Quality Improvement Plan has been fully implemented. CAPA; C-H; MDR; QC/QS; Doc. 14105W

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