
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 