Zyno Medical LLC
Product: infusion pumps
Failure to establish and maintain procedures to control product that does not conform to specified requirements, and to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). For example:
Your firm did not open a non-conforming report (NCR) on 7/30/15, when over (b)(4) Z-800F infusion pumps had a flow rate outside your specification when tested at Test Station (b)(4).
Your NCR dated 8/12/15 documented that (b)(4) Z-800F and (b)(4) Z-800 Infusion Pumps received from your contract manufacturer had the wrong software installed. The rework performed on these units was not documented.
Your response is not adequate to address the above violation. We acknowledge you will be updating your procedures, re-trained your staff and performed a retrospective review of previous NCR activities. In response to the Warning Letter, you should provide us with a summary of your retrospective review as well as a description of any required corrective actions taken as the result of your review. We will need to verify during a re-inspection that your revised procedures will be implemented effectively.
5. Failure to establish and maintain procedures for acceptance activities that include inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). For example, a review of acceptance testing performed at your facility revealed the following inconsistencies:
The IFU for your Z-800 Infusion Pump recommends that the battery be replaced after one to two years, however, your repair and maintenance work instructions indicates that if the pump is less than (b)(4) years old, the battery does not need to be replaced.
The Flow Rate Accuracy testing for new pumps includes a total test time of (b)(4) minutes but the Flow Rate Accuracy testing for pumps returned for service, includes only (b)(4) minutes total test time.
The Z-800 Testing & Calibration Work Instruction does not include instructions to verify that the current software version is installed on devices received from your contract manufacturer.
FDA District: New England District Office