FDA letter: STAAR still in violation

MONROVIA, Calif. — The Food and Drug Administration has informed STAAR Surgical in a letter that the company “has failed to adequately correct numerous violations” identified in a site audit last year, according to STAAR.

The letter, received by STAAR on July 5, also states that the FDA is “gravely concerned about STAAR’s serious, continuing violations and is prepared to seek the appropriate remedies,” STAAR announced in a press release. The FDA letter gives STAAR until July 15 to respond to the letter, according to STAAR officials.

“We have refocused the entire organization on the need for us to reach full compliance with FDA rules and regulations and conform to both the letter and the spirit of the regulations,” said Don M. Bailey, STAAR’s chairman of the board, in a Web cast. “I speak for the entire board when I tell you we take these issues with the utmost seriousness and are totally committed to resolving them to the FDA’s total satisfaction.”

Company officials said a written response from STAAR will be given to the FDA before the deadline. It will include data gathered by STAAR and information about ongoing corrective actions taken by STAAR following its latest update to the FDA, which was submitted in February, the company said.

“There can be no assurance that STAAR’s responses to the most recent letter will resolve all of the open issues to the FDA’s satisfaction,” the release added. STAAR noted that the company cannot predict the FDA’s reaction to STAAR’s response.

STAAR’s most recent communication from the FDA related to written responses that STAAR provided to the FDA in February, which addressed observations made by FDA in September 2004, the company said.

The company “believes that the FDA will pursue enforcement action against the company if it finds the response inadequate,” the release said. “This action, if taken, would most likely have a material and adverse impact upon STAAR and its prospects.”

Also speaking in the Web cast, STAAR Chief Executive Officer David Bailey said the company, in addition to addressing the specific items identified in the FDA letter, will also address a footnote to the letter asking for a complete review of all the company’s regulatory processes

“The FDA did not give us 10 days to remedy any nonconformities, but to demonstrate that we have remedied all nonconformities either known or unknown,” David Bailey said.

During a question and answer session, the CEO told reporters and investment analysts that this is a “normal process” by the FDA to resolve issues with manufacturers.

“We welcome the opportunity to provide further substantive updates to the FDA within the context of the feedback we have received from them within this letter,” he said.

STAAR’s shares fell 23% in morning trading after the announcement of the letter and the subsequent Web cast.

STAAR said in its press release that it believes the FDA will not approve the company’s Visian ICL until all compliance issues are resolved. The lens is in use in some 40 countries.