
Information Request, August 1, 2011 - Anascorp

 
 


From:        Ertel, Donald

Sent:          Monday, August 01, 2011 3:36 PM

To:             'Jennifer Spinella'; ----(b)(4)----

Cc:             Waites, Nancy; Fisher, Robert

Subject:     Information Request

 

Jennifer and (b)(4),

 

I have an information request in support of the review of:

 

STN 125355/0

Anascorp®, Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection

 
1.Is an AQL sampling for visual inspection being performed for the final container (vial) after the 100% visual inspection and prior to release? If so, what are your sample size and acceptance limits?
2.Have you performed bioburden log reduction studies for the -----------------(b)(4)-------------- the lyophilizer? If so, per what protocol and what was the log reduction required?a.What --------(b)(4)-------- were studied? What contact time, temperature, and rinsing was required?
b.How did you test for --------------(b)(4)---------------, and what was the acceptance limit?

3.At what step in process is the sample taken for sterility testing for the Bulk? Is the sample taken directly from the bulk container?

 

I will follow-up with a phone call.

 

Don Ertel

 

__________________________________________________________________________________

__________________________________________________________________________________

 

Donald Ertel

Consumer Safety Officer

FDA/CBER/OCBQ/DMPQ

1401 Rockville Pike, HFM-675

Rockville, MD 20852-1448

Office: 301.827.7121

Fax: 301.827.3536