The St. Paul, Minn.-based medical device company shrugged off the formal warning letter, which follows a so-called "Form 483" from the federal watchdog agency detailing 11 problems with quality control and documentation procedures at the Sylmar facility.
"The FDA letter notes that it will not grant requests for exportation certificates to foreign governments or approve pre-market approval applications for Class III devices to which the quality system regulation deviations are reasonably related until the violations have been corrected. The warning letter does not, however, identify any specific concerns regarding the performance of, or indicate the need for any field or other action regarding, the Riata ST Optim or Durata leads or any other St. Jude Medical product," according to the filing. "Accordingly, the Company will continue manufacturing and shipping product from the Sylmar facility and customer orders are not expected to be impacted while we work to resolve the FDA’s concerns."
Last week, CEO Daniel Starks spent considerable energy trying to reassure investors at the J.P. Morgan healthcare conference about the problems in Sylmar, explaining why the Durata line was a sure thing, and why the Riata lead recall and FDA warnings related to a St. Jude manufacturing plant were no threat to the company’s hold on the larger ICD market.
The SEC filing made the same points, saying that St. Jude "has taken the appropriate regulatory circumstances into account in managing its business and setting investor expectations and believes the FDA’s concerns can be resolved without a material impact on the company’s financial results."
A week after Starks hipped investors to the possibility of a Form 483 in October, St. Jude revealed that the FDA came through on the threat, issuing a heavily redacted copy of the missive. A much less censored version made headlines the following month, disclosing further detail about the 11 problems found in Sylmar during FDA inspections from Sept. 25 to Oct. 17, 2012.