By Anna Yukhananov
March 6 U.S. regulators warned Swiss
medical device maker Synthes Inc about violations at
its plant in Pennsylvania, and said the company may have to pay
a fine if it fails to fix the problems.
Synthes, which is in the process of being bought by Johnson
& Johnson, did not have a good way of monitoring and
investigating complaints about its devices, the Food and Drug
Administration said in a warning letter posted online on
Synthes' manufacturing issues come after Johnson & Johnson
had its own series of high-profile product recalls and quality
control problems with products such as infant Tylenol and
In the letter dated Feb. 16, the agency said Synthes failed
to report serious complaints about its devices to the FDA within
30 days, as required by law.
"Failure to promptly correct these violations may result in
regulatory action being initiated by the Food and Drug
Administration without further notice," Kirk Sooter, director of
the FDA's Philadelphia district office, wrote in the letter.
"We will co-operate and work diligently with the FDA until
these deficiencies are fully resolved," Synthes spokesman
Gilgian Eisner said in an email. J&J referred comments or
questions to Synthes.
Synthes makes artificial spinal disc implants and other
products used in spine surgery, as well as plates, screws and
rods used to repair the bones of trauma patients. The company
generated sales of $4 billion last year.
J&J agreed to buy Synthes for $23.1 billion, its
largest-ever acquisition, but must first gain approval from
The FDA found the Synthes violations during an inspection of
its plant in West Chester, Pennsylvania, carried out June 22
through Sept 15 of last year. The FDA said Synthes responded to
its initial complaints on Sept. 29 but the agency did not have
evidence that the company had corrected the problems.
The full FDA letter can be found here:.