The FDA flagged two overseas facilities for inadequate medical device reporting and improper handling of nonconforming products, and cited a Florida devicemaker for numerous issues observed in a July inspection.
Lumenis: A medical device manufacturer in Yokneam, Israel failed to submit adverse event reports to the FDA within 30 days after becoming aware of numerous complaints that warranted them, the agency said.
According to a Form 483, FDA investigators who inspected the Lumenis facility from Jan. 30 to Feb. 2 observed that at least nine customer complaints should have been reported as MDRs.
These included complaints for patient burns caused by the firm’s LightSheer Desire device; first and second degree burns caused by its LightSheer Duet device; and a patient extended surgery, stiches and open wound caused by a malfunction of its VersaCut+ Tissue Morcellator system.
Several months went by from the time that Lumenis became aware of these adverse events to when these were reported.
There was also a complaint from a patient who lost hair after receiving acne treatment with the M22 Acne Filter that the firm did not report as an MDR. Instead, it initiated a recall of the filters in November 2015, though the FDA wasn’t made aware of that until April 2016.
In addition, the company’s MDR procedure includes a requirement for maintaining a list of product malfunctions, but “management acknowledged that the list did not exist,” the agency said.
Out of the 12 identified nonconformities, four were related to the firm’s design procedures. For example, Lumenis failed to adequately document design validation results for its VersaCut+ device, and to revisit the design plans “as the design and development milestones and the responsibilities for implementation evolved,” the investigators wrote.
The firm’s procedures for CAPA actions, accepting incoming products, conducting quality audits, and identifying products during all of their lifecycle stages, as well as one of its approved process validation were also flagged as inadequate.
FMI Medisch: FMI Medisch’s manufacturing facility in Schiedam, The Netherlands drew a Form 483 over processes for reworking nonconforming products and accepting incoming products.
The rework activities were performed without an evaluation of whether they would lead to any adverse events, and they had not received the required approval, the agency’s investigator found during an April inspection.
FMI also lacked documentation for procedures to control nonconforming products.
With regard to product acceptance activities, the inspection revealed that a sampling plan was being used for the inspection of incoming raw materials for manufacturing implantable devices for which there was no valid statistical rationale. The company also failed to document and maintain its acceptance activities in device history records.
Other nonconformities included an inadequate process validation procedure, and a lack of documentation for the monitoring and control parameters.
Applied Neuroscience: The FDA cited devicemarker Applied Neuroscience of Largo, Florida for failing to correct numerous nonconformities dating as far back as 2014.
Over the course of two days in July, the FDA conducted an inspection at the facility and observed that seven of eight issues identified were repeat deficiencies, including a lack of procedures for design control, as well as inadequate procedures for quality audits, adverse event reporting, and controlling purchased products and documents.
For example, no training was provided to the executive assistant who had been conducting quality audits at the facility, the investigator said.
Another repeat deficiency identified during the July inspection was the firm’s procedure for management reviews, which was deemed inadequate because it did not include requirements for the review of the suitability and effectiveness of the quality system and for the results of the quality system reviews to be documented.
The lengthiest repeated deficiency related to inadequate procedures for CAPA actions. According to the investigator, the firm’s procedure for establishing CAPA action requirements failed to adequately describe the requirements for analyzing quality data, investigating the root cause of an identified nonconformity, verifying or validating a CAPA action to ensure effectiveness, among others.
Inadequate complaint handling was the only new observation. The firm had not implemented its complaint handling procedure, which was found to be lacking a complaints definition, and a requirement to evaluate all complaints to determine which ones need to be investigated.
Read the Lumenis Form 483 here: www.fdanews.com/11-16-17-lumenisltd483.pdf.
Read the FMI Medisch Form 483 here: www.fdanews.com/11-16-17-fmimedischbv483.pdf.
Read the Applied Neuroscience Form 483 here: www.fdanews.com/11-16-17-appliedneuroscienceinc483.pdf. — Ana Mulero
Tips for Managing Nonconforming Product
Devicemakers must maintain procedures that inform employees how to identify nonconformances. Usually, this takes the form of marking the product or lot with a red tag or label, and then segregating it from the rest of the flow of material so it doesn’t accidentally get distributed.
Next, companies need to make sure they have adequate documentation, which takes the form of quality records that keep track of every step of the process. They need to evaluate the nonconformances and execute a series of decisions, including whether disposition is necessary.
Devicemakers have to figure out what to do with the nonconforming material, with the evaluation step answering whether or not an investigation is needed. Then they have to decide who to notify, which means all responsible parties.
Documentation is essential here because the FDA will ask for a record of notification, the decision to investigate or not, what was discovered if an investigation was conducted, and what final decision the company reached about disposition and any corrective actions to keep the nonconformance from recurring.
A robust system of internal quality audits should include examination of nonconformance management procedures and their documentation. A quality management system that can spot and deal with nonconformances effectively can save devicemakers from production errors, recalls, product liability suits and especially FDA censure.
Excerpted from the FDAnews management report: Managing Nonconforming Product: A Devicemaker’s Guide to Compliance.