483 Roundup: FDA Cites Three Firms for Complaints, Validations

July 5, 2019

The FDA rapped three devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes.

Pacific Medical Group: Failure to investigate complaints that certain devices did not meet specifications resulted in a Form 483 for Pacific Medical Group of San Clemente, Calif., following a Feb. 6 to March 14 FDA inspection.

The facility was cited in 2014 for failing to investigate returned fetal cable transducers and electrode cables that were not functioning. It also failed to investigate the root cause of the failure of the devices, which reoccurred after devices were returned to customers. At least 17 devices were reported as not functioning.

“Your firm failed to investigate the device malfunction, resulting in a use of the device [that] caused [a] burn or red mark on a patient,” the agency said, adding that the firm also failed to evaluate complaints for medical device reportability to the FDA.

Investigators found no records of corrective and preventive actions, or records of risk management activities for fetal transducers, the agency said.

In addition, the firm had not established design control procedures and it lacked design history, design specifications and design change records of fetal transducer.

The facility also failed to conduct design validation studies following a change in supplier for a cable. And the facility’ procedures for final inspection and product acceptance didn’t identify or specify required tests to be performed to meet specifications.

Preservation Solutions: A Feb 19 to March 12 FDA inspection of Preservation Solutions’ Elkhorn, Wisconsin facility revealed that the firm failed to correctly validate its aseptic processes for manufacturing and processing sterile organ transplant preservation solutions.

Test data didn’t support specified requirements for several lots of product, and the firm didn’t handle this as a protocol deviation or failure for the initial or subsequent testing. It also failed to meet ISO requirements referenced in the product.

“Your firm lacks an approved process validation for the bag leak test of the sterile organ transplant preservation solution at the time of final packaging for distribution,” the Form 483 says, noting that complaints were received that led to a recall of the solution.

An investigation identified additional units from different lots that were in available inventory that were subject to leaks, but the units were released as acceptable without detecting the bag leaks.

The FDA investigators found that the firm replaced the clean room floor in the aseptic processing area but failed to perform qualification studies to evaluate the potential bioburden impact of the floor replacement.

Performance Health Supply: Failure to establish procedures for process changes as well as documentation and CAPA lapses led to a seven-item Form 483 for Performance Health Supply following an April 8-17 FDA inspection at its Cedarburg, Wisconsin facility.

The supplier of physical therapy products failed to follow procedures for a process change request for a new water system that was installed to eliminate manufacturing nonconformities. The firm also failed to validate the system and to evaluate risk.

The investigator noted that a change request was also missing for a software update performed on the waterjet system. The firm received at least four complaints that the product didn’t meet specifications following the software upgrade. Also lacking were established process parameters for injection molders used to manufacture orthotic splints.

Read the Pacific Medical Group Form 483 here: www.fdanews.com/07-05-19-pacificmedicalgroup483.pdf.

Read the Preservation Solutions Form 483 here: www.fdanews.com/07-05-19-preservationsolutions483.pdf.

Read the Performance Health Supply Form 483 here: www.fdanews.com/07-05-19-performancehealthsupply483.pdf.

Linking Complaints to Risk Management

Complaints, adverse events and MDRs all provide information about instances when production, storage or use of a device may not be going as intended. These can be situations in which previously unrecognized hazards exist or known hazards unexpectedly arise, such as a particular manufacturing facility not following all quality management procedures, says quality expert Dan O’Leary of Ombu Enterprises.

Some common risk management activities to take in such cases include evaluation of all prior activities, examination of manufacturing procedures to see if something needs to be updated and performance of internal audits to identify causes of known issues and to catch unknown hazards before they have a chance to make it to the complaint or MDR stage.

The globally accepted risk management standard for medical devices, ISO 14971, sets forth a method for analyzing hazards, predicting the resulting harm and estimating the severity and probability of the risk associated with a particular device. Devicemakers usually conduct this analysis in the design phase, which allows them to take steps to reduce risk to an acceptable level. They then monitor production and post-production information, such as complaints and MDRs, and react accordingly.

While not all device manufacturers apply ISO 14971 specifically, the broader concept it presents of risk management from design through marketing can be applied to meeting U.S. regulations.

To estimate risk, a devicemaker must first identify all hazards that can occur during correct use of a device in normal conditions. O’Leary recommends against using failure mode and effects analysis (FMEA) for risk assessments, as this technique only addresses singular faults. Device companies must look at hazards associated with a sequence of events.

The severity and probability of the potential hazards, as well as the probability of the hazard occurring and the probability that it leads to patient harm are used to measure the degree of risk. Under this scheme, the inputs for risk analysis include hazards and hazardous situations. The output is the estimated risks.

Once the risk has been analyzed and quantified, the devicemaker can tackle the task of risk reduction, which means putting measures in place that reduce the risk to acceptable levels.

Excerpted from the FDAnews management report: Complaint Management for Devicemakers — From Receiving and Investigating to Analyzing Trends.