News

FDA Finds Multiple Violations at Sharplight Technologies


Posted in Quality Assurance by MDDI Staff on January 16, 2014

The Israeli maker of powered surgical laser instruments failed to maintain and establish procedures for verifying and validating device designs, among a long list of other violations.


By Jim Dickinson
                   
An FDA inspection at Sharplight Technologies in Rishon Le Zion, Israel, last June found Quality System Regulation and other violations in the firm’s manufacturing of powered surgical laser instruments, according to a warning letter issued to the company on November 25. Specific violations noted on an FDA-483 included the following:

Learn what mistakes to avoid during an FDA inspection at the MD&M West conference in Anaheim, CA, February 10–13, 2014.

  • Failing to establish and maintain procedures for verifying the device design.
  • Failing to establish and maintain procedures for identifying, documenting, validating, or, where appropriate, verifying, reviewing, and approving design changes before their implementation
  • Failing to establish and maintain procedures for validating device design.
  • Failing to establish and maintain procedures to ensure formal documented reviews of the design results are planned and conducted at appropriate states of the device’s design development.
  • Failing to establish and maintain plans that describe or reference the design and development activities and define responsibilities for implementation.
  • Failing to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications unless such investigation has already been performed for a similar complaint and another investigation is not necessary.
  • Failing to review and evaluate all complaints to determine whether an investigation is necessary and, when no investigation is made, to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.
  • Failing to establish and maintain procedures for rework, including retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications.
  • Failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record.
  • Failing to establish and maintain procedures for changes to a specification, method, process, or procedure.
  • Failing to establish and maintain procedures to control all documents.

FDA says the inspection also found nonconformances with the electronic product radiation control provisions of the Federal Food, Drug, and Cosmetic Act, including failing to permanently affix or inscribe a certification label or tag.
The company was told to respond with a list of specific steps taken to correct the violations, documentation of each step, and a timetable for completion.

Learn what mistakes to avoid during an FDA inspection at the MD&M West conference in Anaheim, CA, February 10–13, 2014.

—Jim Dickinson is MD+DI's contributing editor. 
[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]


Tags:
Printer-friendly version
No votes yet

Login to post comments