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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Comments Email, July 10, 2009 - Anascorp

RE: Bioclon food suppliers
From: Beren, Joel
Sent: Friday, July 10, 2009 3:49 PM
To: Fisher, Robert
Subject: Re: Bioclon food suppliers

That's OK, I would like them to keep a log of the testing so we can review the
results.
Sent remotely via Blackberry
 

From: Fisher, Robert
To: Beren, Joel
Sent: Fri Jul 10 15:40:50 2009
Subject: RE: Bioclon food suppliers
Would you be OK with measuring ------------------(b)(4)------------------?




From: Beren, Joel
Sent: Friday, 10 July, 2009 14:03
To: Fisher, Robert
Subject: Bioclon food suppliers

Hi Robert,
Please find my comments in Blue:

1. Please verify that you will utilize plasma screening procedures, such as
those described in 9 CFR 113.53, to preclude introduction of adventitious agents
into your manufacturing stream. This may be done on the plasma pool in lieu of
testing individual plasma units.
2. In the absence of adequate data to validate cleaning and sterilization
for the needle and tubing set used in bleeding your donor herd, a new sterile
disposable hypodermic needle and sterile disposable IV collection set should be
used for each bleed.
3. Given the excessive bleed volumes and aggressive bleeding schedule, it
is very strongly recommended that the hematocrit of donor horses be measured at
the time of each bleed and one hour post, ----------(b)(4)-------------. Animals
with hematocrits below 25% should not be bled and hematocrits should not drop
below 18% post bleed.
4. You should use unique container identification, such that ----------
------------------------------------------------------(b)(4)----------------
------------.
5. The water source for your donor animals should be monitored to ensure
sufficient quality; an annual report from the municipal water supplier may be
sufficient if contaminants such as toxic organic compounds e.g. herbicides and
pesticides in use in the region are monitored.
6. Please verify that your SOP P-SA-029 establishes adequate deferral
[unsure if deferral is the correct term, normally we talk in terms of withdrawal
time to keep the product out of production (out of the food chain)] times for
each therapeutic used for treatment of your donor herd.
7. We acknowledge your response of 01 May 2009 that indicates horses will
be immunized against --------(b)(4)-----------. Please verify that lots of your
product designated for the U.S. market will be manufactured using plasma from
vaccinated horses.
I think the feed (------(b)(4)-------)should also have a quality assurance
certification perhaps done -(b)(4)-, similar to the (b)(4) water testing.
Best regards,
JB
Joel J. Beren DVM
Chief, Veterinary Services
FDA/CBER/OM/DVS
29 Lincoln Drive
Bldg. 29A/Room 1B-24 (HFM-22)
Bethesda, MD 20892
Tel: 301-402-8187
Fax: 301-402-2408
E-Mail: joel.beren@fda.hhs.gov
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-----Original Message-----
From: Beren, Joel
Sent: Friday, 10 July, 2009 13:00
To: Fisher, Robert
Subject: RE: Bioclon food suppliers
Hi Robert,
It's probably a good idea if we set-up a time the week of July 13th to discuss
some of the outstanding Bioclon issues.
I'm doing NHP work each morning but my afternoons are generally free.
Thanks,
JB
-----Original Message-----
From: Fisher, Robert
Sent: Thursday, July 09, 2009 11:00 AM
To: Beren, Joel
Subject: Bioclon food suppliers
Is it acceptable for them to NOT audit their feed suppliers?
Thanks...this is almost over (for awhile at least!)
Robert W. Fisher, Ph.D.
Staff Fellow
FDA/CBER/OBRR/DH/LPD
301-496-2579
Robert.Fisher@fda.hhs.gov