Surgical Lighting Firm Fails to Validate Design, Evaluate Complaints

October 25, 2019

Failure to validate design under defining conditions, poor documentation and failure to evaluate complaints were a few of the deficiencies observed during an FDA inspection of surgical lighting manufacturer Sunnex’s Charlotte, North Carolina facility.

Sunnex failed to establish written design validation procedures for its surgical and exam lights, and it wasn’t able to provide device history records, according to the 12-item Form 483. The firm lacked a record of its design verification activities for one of its transformers and lacked a process validation plan for its medical lights soldering process.

Service reports for repaired medical lights were missing critical information such as service performed and tests and inspection data. In addition, complaints involving the possible failure of a device to meet any of its specifications were not reviewed or evaluated, the 483 said.

The firm received customer complaints for malfunctioning and nonconforming medical light devices that were not investigated, but it “did not perform root cause investigations to determine the failure mode to prevent reoccurrence of the nonconformities or to identify potentially defective devices that were distributed,” the FDA official wrote.

Sunnex didn’t document re-work and re-evaluation activities in the device history record, and the DHR didn’t record the final disposition of the device components.

The firm’s president told the FDA investigators that Sunnex had not established procedures to ensure the device design was translated into production specifications, and it did not maintain a device master record.

Finally, procedures for finished device acceptance were not established, and documents were not approved by designated individuals. For example, UDI labeling procedures weren’t approved before being issued, the 483 said.

Read the Form 483 here: www.fdanews.com/10-25-19-sunnexllc483.pdf.

Five Steps to QSR-Compliant Purchasing Controls

The FDA is placing an ever-keener eye on device manufacturers’ purchasing controls, including supplier qualification processes and vendor-related record keeping, as an important part of its Quality System Inspection Technique (QSIT). Although the FDA considers purchasing controls to be a routine part of even the most basic QSIT inspection under the Production and Process Controls section of the Quality System Regulation (QSR), devicemakers are failing to meet basic requirements of 21 CFR 820.50 time and again.

Only six paragraphs in length, 820.50 seems easy enough to digest, but FDA warning letter statistics paint a different picture. Forty percent of 2016 warning letters that cited Quality System Regulation violations included purchasing control problems.

“That tells us that there’s some significant issues that device manufacturers are having in purchasing controls that FDA investigators are uncovering,” says Dan O’Leary of Ombu Enterprises. The ability to find and fix these problems yourself is your best defense against 483s and warning letters, O’Leary says.

But to do that, you first need to go deeper into those six short paragraphs to get at the heart of the FDA’s intentions and build a purchasing controls system that meets them. There are five simple steps, tied closely to the precise regulatory language governing purchasing controls, that can bring devicemakers smoothly from noncompliance to a robust purchasing controls program that meets or surpasses QSR requirements. The five steps are:

  • Evaluate and qualify suppliers;
  • Determine the necessary controls over each supplier;
  • Establish active record-keeping procedures;
  • Establish and maintain purchasing data for all suppliers; and
  • Establish and adhere to appropriate acceptance criteria and activities for all products received from suppliers.

Excerpted from the FDAnews management report: QSR Compliant Purchasing Controls: A Five-Stage Plan.