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Fort Worth, Texas. Alcon P.R. was responsible for the quality of
Avitene, and its employees in its quality assurance department
performed each of the required tests as set forth in the product
specifications owned by MedChem U.S.A. Alcon P.R. kept in its
quality assurance department all master documentation for the
manufacturing of Avitene and all related records such as
inspection documents, charts, and forms. After Alcon P.R.
completed its quality assurance tests and document review, it
used its regular carrier to ship the packaged Avitene to MedChem
U.S.A. in Woburn, where MedChem U.S.A. stored the Avitene in a
warehouse or quarantine cage awaiting distribution to its
customers (i.e., the end users). MedChem U.S.A. performed
secondary quality tests on the finished Avitene product at its
quality assurance department in Woburn. MedChem P.R. did not
have a quality assurance department, and it never tested Avitene
for quality compliance.
MedChem U.S.A. prepared and filed all applications, reports,
and other documents required by the FDA to manufacture Avitene.
Alcon P.R. provided MedChem U.S.A. with information relating to
the manufacturing process, and MedChem U.S.A. incorporated that
information into its FDA filings. MedChem P.R. did not submit
any applications, reports, or other documents to the FDA.
MedChem U.S.A.’s filings with the FDA for the period August 26,
1991, to October 27, 1993, identified Alcon P.R. as Avitene’s
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