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FDA (VACCINE PRODUCTS) LICENSE REVOCATIONS

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Sand-man

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Jul 28, 2001, 11:10:19 AM7/28/01

Subject: FDA (VACCINE PRODUCTS) LICENSE REVOCATIONS

HOLLISTER-STIER LABORATORIES, LLC
& BIOPORT CORPORATION
FDA (VACCINE PRODUCTS) LICENSE REVOCATIONS

What I would assume to be of interest, to all who have
been following the anthrax vaccine debacle, with problems
at Bioport and the recent announcements that partnering will
be done with Hollister-Stier Labs to avoid production down
time and other difficulties, it looks like both are having
troubles
with the FDA over their vaccine products, FDA has revoked
vaccine product licenses at both companies as follows:

Hollister-Stier Laboratories, LLC
U.S. License 1272 for polyvalent Bacterial Vaccines,
with " no "US Standard of Potency" was revoked.
Although a "voluntary" revokation, it took place only
after the Vaccine and Related Biological Products
Advisory committee (VRBPAC) declared the vaccine
to be a catagory II (unsafe, ineffective, or misbranded)
product.

Bioport Corporation
License 1260 for manufacture of Diptheria and Tetanus
Toxoids and Pertussis Vaccine Adsorbed, Diptheria and
Tetanus Toxoid Adsorbed. Other products under this
license were not effected. This revocation was also
"voluntary"
but occurred only after products were declared to be catagory
II
products by VRBPAC.

(Source: BioQuality, Volume 6 Issue 6, June 2001)

NOTE:"voluntary" with quote marks added, by this sender,
means
"caught with their pants down and now trying to save
face"......rgs

--
Kansas Veterans Home Page
http://www.geocities.com/kansasvet

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