Sandstone to Stop Imports
BIRMINGHAM, Ala., June 16, 2008 -- A US Food and Drug Administration (FDA) warning has prompted, in part, a small Alabama laser company to expand its US manufacturing operations.
Sandstone Medical Technologies LLC, a Birmingham-based producer of new and reconditioned lasers used in medical and cosmetic applications, said it will also take steps to better control the quality of its repairs, parts and support as a result of the FDA letter, sent on May 30.
Mark C. Rohrer, president of Sandstone Medical Technologies, said the company has been importing its dual-wavelength 1064/532 Ultralight-Q laser, used for tattoo removal and pigmented lesions, and its LS25 CO2 laser, used for dermatological and plastic surgery procedures including skin rejuvenation and removal of lesions, from out of the country. Parts for the systems will continue to be imported, he said, but the final assembly and testing of the units will take place in Birmingham. Later this month, Sandstone Medical Technologies will be moving into a new 7000-sq-ft facility where the lasers will be manufactured.
A separate company, Medical Laser Technologies Inc. -- also known as MLT International Inc. LLC -- in Austin, Texas, already makes its Whisper-ng erbium laser system, used for laser peels. The devices made by both companies are sold primarily to medical markets. Rohrer is the managing member of both Sandstone and MLT. The companies have been in operation since 2000 and have a total of 13 employees.
Since 2000, The FDA has conducted three inspections of Sandstone Medical Technologies LLC's Birmingham facilities. "The April inspection is the first time we have received any violations," Rohrer said. "We have already began the process to obtain the required paperwork that we were deficient in. Once the paperwork is complete, Sandstone Medical Technologies will comply with the FDA’s manufacturing guidelines."
Rohrer said MLT was audited by the FDA within a week of those inspections but was issued no warnings. The subsequent letter from the FDA also cited Sandstone for violations of manufacturing regulations, including adulterating, mislabeling, misbranding and failing to ensure adequate quality control for its laser systems and to file proper paperwork. It referred to seven reports of UltraLight-Q malfunctions between March 2006 and February 2008. The service reports included descriptions such as "did not turn on," "not firing or fires by itself," "burned patient," "low power" and "will not fire."
Rohrer said those problems occurred because of "quality startup issues, as there are with all new devices, with the lasers being imported." (The devices were imported for a total of approximately three years, he said.) He said the malfunction reports are at least 24 months old and that the UltraLight-Q "has been a bullet-proof unit for the last two years."
The FDA's claims that its lasers were adulterated or misbranded are "incorrect," he said, since they had already been reviewed by the FDA. A 510k (premarket) approval (K041011) was issued to Sandstone for its Ultralight II Nd:YAG laser system on Dec. 14, 2004. The Ultralight II was recently renamed the Ultralight-Q.
Rohrer said Sandstone has already begun manufacturing the devices and will implement better quality-control and final test procedures. "Even after final test is completed, before we ship out any products to end users, they're checked," he said. The company also sells used laser systems, most of which he said it buys from physicians.
The reported filing problems were a result of the transition to manufacturing the devices and the failure to submit "additional paperwork that we weren't aware we had to have," Rohrer said. A consultant is "helping us get the paperwork where it needs to be," he added.
The company had already decided to manufacture in the US rather than import its devices even before receiving the FDA letter, Rohrer said -- a decision also influenced by the economy, the weak dollar and rising fuel costs.
For more information, visit: www.sandstonemedicaltechnologies.com/
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