| FDA
Update for bioMérieux Customers
September 2, 2004
Dear bioMérieux customer,
As a supplier to the healthcare industry, bioMérieux Inc
operates in a regulated environment. At any time we can have inspections
by the U.S. Food and Drug Administration (FDA). Over the past
several months, FDA inspected two major bioMérieux Inc
U.S. manufacturing sites, located in St. Louis, MO and Durham,
NC. This letter is intended to share the findings of these inspections
and subsequent corrective actions, and to reassure you that manufacturing
continues at normal capacity in all sites for all products.
bioMérieux takes these FDA observations seriously and
has already implemented a number of changes to ensure complete
compliance with the regulations. The company has dedicated all
necessary resources to address the issues; the bulk of which were
related to processes and procedures rather than specific products.
We see this as an opportunity for improving our organization
and the company is committed to working in partnership with the
FDA, and thus will be stronger as a result of this process. Notably,
bioMérieux immediately implemented the
changes in reporting structure recommended by the FDA. In addition,
the Quality teams have been significantly expanded and will increase
regular audits of complaints and processes to ensure adequate
investigation and reporting of potential issues.
To further address complaint-handling observations, our complaint
handling and review processes have been updated. Specifically,
our customer service staff has been retrained and a rigorous certification
process has been installed.
I recognize bioMérieux products are often essential in
determining the course of patient care. Be assured that manufacturing
continues at normal capacity and that the products meet all proper
release specifications. Following, please find details of each
FDA site visit.
St. Louis
The inspection of the St. Louis site resulted in two observations
– both of which were of a documentary nature and have
been closed by the FDA. VITEK 1 and VITEK 2 reagents and instrumentation,
MDA II and Coag-A-Mate XM instruments and BacT/ALERT instrumentation
are manufactured in this facility.
Durham
The inspection of the Durham site resulted in a Form 483 and
a subsequent Warning Letter. BacT/ALERT reagents, hemostasis
reagents and immunoassay reagents are manufactured in the Durham
facility. This inspection only covered the BacT/ALERT and hemostasis
areas. Observations were related to issues with processes, procedures,
organizational structure and product performance.
Internal task forces, under the guidance of external consultants
and industry experts, are actively addressing the process, procedures
and product observations. To date, the company has completed
most of the action items and expects to have the majority of
the additional items addressed by the end of the year.
With regard to the issues outlined for BacT/ALERT bottles,
the conversion, in July 2003 to plastic bottles, included several
upgrades to the manufacturing facility and processes to reduce
bio-burden. More recently, in-process and release specifications
have been tightened to more accurately reflect the enhanced
manufacturing capabilities. As a result, these changes have
further improved the quality and further reduced contamination
rates of the BacT/ALERT bottles.
Regarding our coagulation range of products, root-cause analysis
of product variability has resulted in changes to incoming raw
material specifications and testing for both Fibriquik and Simplastin
L. With regard to product performance observations, five lots
of Fibriquik were recalled in August. A long-term stability
program has been completed and expiration dating adjusted. No
further recalls are anticipated.
The company, as always, is devoted to continuing to upgrade processes,
procedures and systems to ensure the highest standards for patient
safety. We recognize you may have additional questions and we
are dedicated to addressing any concerns. If you have any questions,
please contact myself or Herb Steward, Sr. VP of North American
Commercial Operations, at 919-620-2000.
Thank you for your time and patience as well as your continued
use of bioMérieux products.
Sincerely,
Eric Bouvier
President and CEO
Corporate Vice President for North America
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