Durham, N.C.
Following the inspection of the Durham, N.C. site, the FDA
issued a Form 483 and has subsequently restated these observations
in a warning letter.
bioMérieux takes the observations seriously and is committed
to working with the FDA to swiftly and comprehensively address
the observations. In response to the FDA correspondence, bioMérieux
submitted recommendations for corrective actions on May 20,
2004. All means are being utilized for implementing these action
plans. In fact, the company has already taken certain corrective
measures, while other corrective actions are being studied with
the help of consultants.
At this stage, the potential consequences for product development
at the Durham site could be suspension of applications for new
approvals of Class III products, and the suspension of Certificates
For Export for products where new or renewed approvals need
to be obtained per requirements of certain countries.
St. Louis, Mo.
The inspection of the St. Louis, Mo. site resulted in two
minor observations - both of which were of a documentary nature
and have already been closed by the FDA.
bioMérieux views the FDA as a partner in the quality control
process. The company appreciates the agency’s role and help,
and is committed to continuing to develop and deliver diagnostic
tests that improve or save lives.
bioMérieux also recently obtained approval for two important
tests for its VIDAS range in the U.S.:
- A “501k” relating to a pulmonary embolism indication
for Vidas D-Dimer Exclusion was granted. The addition of this
new indication allows doctors to use this test in the context
of the exclusion of pulmonary embolisms. Vidas D-Dimer Exclusion
is currently the only test available for this diagnosis in the
U.S. market.
- A “Pre-Market Approval” (Class III approval)
was received for VIDAS TPSA. The approval permits the utilization
of this test as an aid to the diagnosis of prostate cancer,
in addition to its current application as an aid to the monitoring
of patients afflicted by the same disease.
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