483 Roundup: FDA Cites Devicemakers for Inadequate CAPAs, Investigations

March 30, 2018

The FDA flagged two U.S. facilities and one in Germany for a variety of deficiencies including CAPA failures and investigations of nonconforming products.

HQ: Inadequate CAPA procedures and failure to investigate failures of the CorTemp ingestible core body temperature sensor devices landed devicemaker HQ a Form 483 following a September 2017 FDA inspection of its Palmetto, Florida facility.

The FDA inspector noted that the firm failed to initiate corrective and preventive actions on at least four occasions for high numbers of nonconforming products.

Nonconforming products were not discussed in meetings and the facility had no records of an investigation of environmental control conditions that may have affected electrostatic discharge. Records didn’t indicate whether there was an investigation to determine if component suppliers made changes to the product or whether they failed to control their production processes.

At least six of 11 complaint records failed to document a complete investigation into the malfunctioning CoreTemp devices. In a few cases the investigation was limited to a review of the device history records, and a few potential causes for the failures were listed but apparently were not followed up. This was a repeat observation from a July 2012 inspection.

The firm was cited for failing to develop written procedures for medical device reporting as well as failing to control products that didn’t conform to specifications. The FDA inspector said the firm was not taking measures to prevent damage to sensitive electronic components from electrostatic discharge, and the acceptance status of products was not identified to indicate conformance or nonconformance with acceptance criteria.

The inspector observed documents in the production workflow that had not been approved. The 483 noted that a production employee said the procedure had not been formally approved yet but it was being used for current work instruction. This was also a repeat observation from the 2012 inspection.

Maico Diagnostics: Maico Diagnostics received a Form 483 following an October 2017 inspection for its failure to have a formally designated unit to handle complaints, quality audits and procedures for design review.

Complaints involving possible failure of devices to meet any of their specifications were not reviewed, evaluated or investigated, the 483 said. For example, a number of failures were noted and closed without any investigation or analysis of service records.

The firm’s complaint handling procedures didn’t require that complaints be handled in a uniform and timely manner, and they didn’t require information on whether the device is used for treatment or diagnosis. Complaint procedures didn’t require a unique device identifier or universal product code.

In addition, the written medical device reporting procedures didn’t include an internal system for identifying events that may be subject to MDR requirements.

Finally, the firm had not established procedures to conduct quality audits to be sure it was in compliance with quality system regulations. The 483 noted that Maico had “an extensive backlog of unresolved complaints and servicing records from 2016 to 2017.”

Unique Instruments: Mississippi’s Unique Instruments racked up a nine-item Form 483 for numerous quality system failures observed at its Bridgeport facility during an October 2017 inspection.

The sterile packaging process was not properly validated for the company’s Paradigm Spine Coflex Interlaminar devices. For example, during the installation qualification conducted in 2015, not all preventive maintenance requirements were completed. Inspectors noted that during the operational qualification the temperature range was limited, and the firm was unable to provide objective evidence that packages were sealed at the parameter settings defined in the protocol.

The 483 said the firm failed to establish procedures for monitoring and controlling process parameters for a validated process, procedures to control environmental conditions and corrective and preventive actions.

One of the firm’s operators told inspectors that when an in-process inspection failed to meet specifications, the initial failed result and the reason for scrapping devices were not documented.

Read the HQ Form 483 here: www.fdanews.com/03-29-18-hqinc483.pdf.

Read the Maico Diagnostics Form 483 here: www.fdanews.com/03-29-18-maicodiagnosticgmbh483.pdf.

Read the Unique Instruments Form 483 here: www.fdanews.com/03-29-18-uniqueinstrumentsinc483.pdf.

Gathering Information on Complaints

Since frontline employees often field the initial complaint, they should receive training in how to gather information for the investigation that will follow.

The following questions are important when investigating a complaint:

  • Who is providing the information?
  • What happened?
  • Did the device malfunction?
  • Was the patient injured?
  • Was the event (or clinical study) related to the device?
  • What was the severity of the injury?
  • How was the issue resolved?
  • What was the device lot or batch number?
  • Was the device reprocessed?
  • Had the device reached the end of its life? and
  • Is the device available for analysis?

The more information employees can dig out, the better the company will be able to resolve the issue. If the problem is the result of user error or misuse of the device, the whole picture can change.

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