UPDATE 1-St. Jude: FDA lists concerns about Sylmar, Calif., plant
Oct 24 (Reuters) - St. Jude Medical Inc said it received a Form 483 n otice from the U.S. Food and Drug Administration about its Sylmar, California, manufacturing plant, where it makes cardiac rhythm management products.
The medical device maker told analysts last week that it expected to receive the notice.
A Form 483 from the FDA is a notice that lists its concerns after conducting a quality inspection. It may or may not lead to a formal warning letter.
The company said in a government filing that it will provide written responses to the FDA's 11 observations no later than Nov. 7. St. Jude said it does not expect remediation to have a material impact on its financial results.
``It is important to note that none of the observations identified a specific issue regarding the clinical or field performance of any particular device,'' the filing said.
``The Sylmar, California, facility will continue to manufacture cardiac rhythm management devices while the company works with the FDA to address these observations.'' Bernstein Research analyst Derrick Sung said in a note to clients that he believes the Form 483 will eventually lead to a warning letter.
``We continue to believe, however, that the near-term impact to STJ's business is minimal,'' he added.