FDA Gone Rogue
Sounds like the FDA is just trying to tank the stock of big lasik companies by sending out nonsense warning letters without any real guidance. Typical govt agency BS. Some LASIK lobbyist must not have paid his bill or some middle manager at the fda with a job like big pharmcos.
Here’s TLC’s response:
TLC Vision Corporation (TLCV) has responded to a FDA announcement regarding warning letters issued to LASIK facilities.
James B. Tiffany, President and Chief Operating Officer of TLCVision, commented, “Over the course of the last 4 months, six TLCVision refractive surgery centers were inspected by the FDA. This was a limited, directed inspection and assessment of the firm’s compliance with statutory reporting requirements.
“We continue to seek clarification from the FDA on the recently issued warning letters. However, the FDA investigators, issued no objectionable or adverse findings at the centers in which we received their establishment inspection reports. One center was noted to need additional written procedures as outlined in a letter received from the FDA on August 20, 2009. On September 4, 2009, we responded to the FDA that we have already begun the process to enhance our existing reporting procedures in that center.
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