Repro-Med Slammed With Warning Letter Over Quality System, MDR Violations
Chester, N.Y.-based Repro-Med, a manufacturer of infusion pumps and intravascular administration sets, has earned an FDA warning letter for failures involving quality systems and medical device reporting, as well as other violations.
The Feb. 26 warning letter, which follows a June 3 to 23, 2015 inspection, says the company failed to get FDA permission to change the specification ranges for pressure and flow rate for its Freedom 60 syringe infusion pump.
The warning letter also says Repro-Med is promoting its Freedom 60 syringe infusion pump for indications that fall outside the cleared intended use, such as the infusion of immunoglobulin G, antibiotics, Desferal, pain medication, chemotherapeutics and cardiac medications.
Further, the devicemaker is marketing its Freedom Edge syringe infusion systems, including the HigH-Flo subcutaneous safety needle sets, for subcutaneous immunoglobulin infusion, even though the company was unable to supply the agency with requested performance data.
In terms of quality systems, the warning letter says the company failed to complete verification activities to confirm that the design output meets the design input requirements, and failed to maintain plans that describe the design and development activities for the Freedom Edge syringe infusion pump.
The FDA says the company’s response to the Form 483 was not adequate. For example, the response did not contain information regarding systemic corrective action, including a retrospective review of other products to ensure that design controls were documented and completed as required.
The warning letter also takes Repro-Med to task for failure to establish procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained, and failure to maintain procedures for retesting and revaluation of nonconforming product after rework, for implementing corrective and preventive action, and for acceptance activities.
The FDA acknowledges that Repro-Med’s response indicates the company will develop a calibration manual and master validation plan, has revised the corrective action process, and will be revising its tubing and needle set flow test procedure. However, the agency was unable to provide an evaluation on the response because the company didn’t provide details.
Finally, the FDA says Repro-Med failed to adequately develop, maintain and implement written medical device reporting procedures. For example, its MDR procedure does not establish internal systems, such as specify who makes decisions for reporting events to the agency, or describe how it will address documentation and record-keeping requirements.
Repro-Med could not be reached for comment by press time.
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