SDL Inc. Clarifies Warning Letter From FDA
Dow Jones Newswires
SAN JOSE, Calif. -- SDL Inc. (SDLI) issued a press release clarifying why it received a warning letter
from the U.S. Food and Drug Administration regarding an alleged problem with the company's Diode
Laser System used in the treatment of eye defects.
In the press release, SDL said the following:
On April 14, 2000, SDL received notice that an on/off key could be removed
from an electrical switch in three different low volume SDL laser diode products
while the lasers were operating. Although this did not affect the operation of
the laser, the defect was cited in an FDA notice as a compliance issue.
SDL responded to the FDA proposing corrective actions. The company also immediately began inspecting
production units for this defect and repaired this defect prior to further product shipments.
By July 5, 2000, SDL also issued recall notices for all 333 units previously shipped, asking customers to
return the units for repair if they found the defect to be present.
SDL's three products for which the notice was issued were reinspected in September by an FDA
inspector. SDL believes the products were found to be in full compliance, based on the corrective actions
taken by SDL.
It should also be noted that none of the products subject to the FDA's notice are used in the treatment of
eye defects, but rather in materials processing and printing applications.
Earlier today, Dow Jones Newswires reported that SDL received a government warning letter about
violations found in its laser systems during an inspection.
The agency said investigators inspected certain models of the company's Diode Laser System in April and
found that keys could be removed from the lasers while the equipment was still in the 'on' position. Forty of
these defective devices were shipped out of the company for sale, according to the letter.
Also, the necessary protective labels weren't present on some models of the company's lasers.
Company Web site: sdli.com
-By George Stahl; Dow Jones Newswires; 201-938-5400 |
