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manufacturer. MedChem U.S.A. also reported to the SEC for most
of 1989 and each of the relevant years thereafter that Alcon P.R.
was Avitene’s manufacturer and that Alcon P.R. manufactured
Avitene at its Puerto Rico facility for MedChem U.S.A.
MedChem P.R. did not have a facility registered with the FDA
to manufacture pharmaceuticals. Alcon P.R.’s manufacturing
facility was so registered, and the FDA performed a yearlong
inspection of that facility beginning in August 1992. During the
inspection, the FDA dealt almost exclusively with employees of
Alcon P.R.; contacts with non-Alcon P.R. personnel were minimal
and insignificant. The FDA’s report on the inspection listed
Alcon P.R. as Avitene’s manufacturer.
MedChem U.S.A. had a department in Woburn where its
employees researched and developed Avitene. During the subject
years, for example, MedChem U.S.A. researched and developed a new
form of Avitene named Endo-Avitene, which it began shipping in
November 1992. Ariel Ferdman generally directed MedChem U.S.A.’s
research and development activities out of Woburn, and he was
assisted in his work by MedChem U.S.A. employees and/or Alcon
P.R. employees. On a few occasions from 1990 through 1992, Dr.
Ferdman (occasionally accompanied by other MedChem U.S.A.
employees) traveled to Alcon P.R.’s manufacturing facility in
Puerto Rico to research and develop Avitene. Dr. Ferdman’s
research and development work at Alcon P.R.’s manufacturing
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