Hil-rom 6/25/98 Isolette C2000 Infant Incubators
Failure to assure that all inspection and testing equipment is suitable for its intended purposes and is capable of producing valid results. The inspection revealed that the _____ automated simulator test has not been updated to keep current with hardware and software changes made to the C2000 device. (FDA 483 Observation 2)
We acknowledge the fact that, on May 8, 1998, your firm voluntarily ceased distributing the C2000 in response to our ultimate determination that these devices represent a moderate risk of serious adverse health consequences and that your firm initiated a Class II recall (consisting of user notification) of devices currently on the market. As representatives from this office have previously conveyed to you and other members of your staff, we consider this recall an interim fix until outstanding CGMP deficiencies can be resolved.
We also acknowledge your efforts to validate the software associated with the _____ automated simulator. However, the inspection revealed that the _____ has both software and hardware components. These hardware components also require validation. In addition, we are unable to fully review the proposed additional production/quality control (QC) tests discussed in the response because the information provided does not include a diagram of the equipment and instrument set-up. In addition, it appears that these additional tests may also depend upon a validated _____ simulator. If you intend to use these tests when you resume shipping this device, then we request that you provide us with the test set-up and also clarify whether or not the additional tests use the _____ simulator.
