The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs / Inspections and Audits

Israeli Laser Maker Lands Warning for Myriad Documentation Issues

Dec. 27, 2013
A A

Sharplight Technologies, an Israeli maker of powered surgical lasers, received an FDA warning letter for failures with quality records and other documents.

Multiple quality records were found to be incomplete, lacking a signature or date, or containing an incorrect sign-off date, according to the Nov. 25 warning letter posted recently online. The FDA investigator also saw a tester using unapproved work instructions during in-process and final tests on a laser used with the Omnimax-C dermatologic treatment system.

During the June 10-13 inspection, the investigator found multiple versions of a revised complaint form that had not gone through the approval process. “Complaint and CAPA logs are not controlled,” the letter says. Meanwhile, the company’s design verification test records for one product did not include required documentation, and it could not provide documentation of the test protocol for the verification testing conducted in one report.

Other documents lacked certain requirements. For example, Sharplight’s engineering change order procedure did not require approval of all changes before implementation. And the company’s design validation procedures lacked requirements to ensure validation testing is conducted before validation activities, the letter says.

Other documentation issues include failure to:

  • Retain copies in the design history file of the design plans reviewed, updated and approved during the design of the Omnimax;
  • Provide records to show that a particular complaint was investigated; and
  • Record the reason an investigation was not required for a separate complaint.

Sharplight’s nonconforming product procedure could also use some work, according to the letter. The procedure does not ensure that rework of nonconforming product includes retesting and reevaluation of the product afterward. It also does not ensure documentation in the device history record of reevaluation activities, including a determination on the possibility of adverse effects. For some of the nonconformance records reviewed, the company could not provide retest records for the device after it was reworked.

Sharplight took heat for its design review procedure as well. According to the letter, it does not ensure participation by representatives from all functions in the design stage being reviewed, nor does it ensure participation by neutral employees with no responsibility for that design stage. The FDA investigator also found that not all of the design review meeting records were reviewed, as required by procedure.

Sharplight was also rapped for noncompliance with the electronic product radiation control provisions of the 1938 FD&C Act. The company could not prove that a certification label or tax is affixed on the Omnimax-C platform dermatologic treatment system with laser technology, and the investigator did not observe such a label on the product, the letter says.

In another labeling citation, not all of the device history records reviewed included copies of the labels and labeling for each finished product.

The FDA wants to see that you have documented all of your operations procedures, along with other procedures carried out at your facility. Need some help? Investigations Operations Manual 2013 will advise you on how to present full documentation to that FDA investigator.