Lomb facing food drug Bureau warning

World Science report ();

When you issue a moratorium on care solution also does not report

United States food and Drug Administration 7, issued a warning letter stated that the United States Lomb company failed to report to the Government as required contact lens care solution — Yun-ming hydraulic full care solution in more than 30 foreign causes sickle cell bacteria infected fact.

The report does not timely

This long 11 page warning letter said that the company failed to follow the Lomb legal provisions, in Singapore health officials to the New York-Rochester's corporate headquarters issued a warning this year, after 7 April, the United States food and Drug Administration report by Yun-ming hydraulic full care solution caused serious damage to 35. At that time, Dr. Edgar company has stopped in Singapore sales Yun-ming hydraulic all-care solution, but still unreported.

Reaction inadequate

Warning letter criticizing the Lomb company that the company report Singapore sickle cell strains keratitis case reaction inadequate. The letter said: "your reactions, this information will not be able to convincingly explain Yun-ming full care solution causes the hydraulic or result in sickle cell bacteria infection. United States food and Drug Administration does not agree with this statement. This information shows that your Yun-ming products caused or partly caused by this incident. ”

Questions to rectification

Singapore has sickle cell bacteria infection case, the United States food and Drug Administration on Lomb corporate production Yun-ming hydraulic factories full care solution. These Yun-ming hydraulic full care solution by the United States South Carolina green sweers of a factory production. Warning letter in detail previously revealed problems of factory production. The letter stated that the United States food and Drug Administration has not found that the company is the production of other products.

Lomb company issued a statement saying, in response to the United States food and drug administration, the company has completed a two-thirds of the corrective action. These issues are the United States food and drug administration in March to may in check green factory discovered sweers. To March 31, the company will provide the United States food and Drug Administration for review.