The QMN Weekly Bulletin
Quality / Medical Devices

483 Roundup: Firms Cited Over Complaints, CAPAs, Quality Issues

June 9, 2017

The FDA cited device manufacturer Medtronic for lack of corrective action procedures and inadequate handling of complaints.

The agency issued a Form 483 following a late January-early February inspection of Medtronic’s Juncos, Puerto Rico, facility. According to officials, the facility did not consistently escalate CAPA quality data sources for investigation to include non-conforming events.

The facility also did not adequately document CAPA investigations, according to the Form 483. One such investigation, opened in May 2015, did not clearly document the results of the proposed corrective actions and the final disposition of the units involved in the investigation. The investigation involved re-testing to correct for an incorrect initial equipment set-up, but the investigation records did not contain the data from the re-testing.

The facility also lacked procedures for receiving, reviewing and evaluating complaints, according to the Form 483. Inspectors found numerous complaints logged in 2016 with no accompanying formal investigation. Medtronic did not respond to a request for comment.

Backjoy Orthotics: The FDA cited device manufacturer Backjoy Orthotics for lacking written procedures and failure to properly handle complaints.

Following a March inspection of Backjoy’s Boulder, Colo., facility, the FDA issued a Form 483. The firm did not have procedures in place for investigating, assessing and documenting adverse event reports, the agency said.

The FDA also found Backjoy’s procedures for reviewing and evaluating complaints were inadequate. The company’s protocols failed to address: uniform and timely processing of complaints; documentation of oral complaints upon receipt; records documenting determinations that no investigation of a complaint was necessary; and evaluation of complaints to determine whether it should be reported to the FDA.

The company did not respond to a request for comment.

Frye Electronics: The FDA faulted Frye Electronics for inadequate design validation and verification as well as incomplete complaint records.

Following an April inspection of the firm’s Tigard, Ore., facility, the FDA issued a Form 483, citing the company’s failure to establish procedures for design validation. Specifically, the company could not document that it conducted the required design validation for every major step of the design process.

The FDA also faulted Frye’s design verification process, noting that its design verification documentation did not demonstrate testing was completed and passed. Its verification checklist for the B-Phase of design also failed to include results in the pass-fail column for several requirements.

Inspectors also found several complaint investigation records were missing required information. One complaint dated August 2014 remained open.

Frye did not respond to a request for comment.

Stryker: The FDA issued a Form 483 to Stryker’s medical division, citing problems with its quality system, design verification and device-servicing procedures.

The FDA issued the form following a February-March inspection of the company’s Portage, Mich., facility. Inspectors found the facility lacked established quality system procedures. In addition, the facility lacked the design verification to support the cleaning and disinfection process outlined in the service manuals for its thermal regulators.

The agency also faulted Stryker on its servicing procedures for equipment. According to inspectors, the firm did not require documentation of test and inspection data for the device-servicing process.

Remember, you have only 15 days to respond to a 483. Most of that time will go toward bringing your CAPA program into compliance. Don't waste a second trying to figure out how to communicate those plans in a way that will convince the FDA you are focused on improvement and committed to quality. Learn from those who have been there. Order now your copy of Effective 483 Responses: Focus on CAPA Violations.

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