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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Request for Compliance Check Email, June 3, 2011 - Kedbumin

From:                     CBER Complicheck

Sent:                      Friday, June 03, 2011 7:35 AM

To:                         Allard, Crystal; CBER Complicheck

Cc:                         Peters, Lori; Jia, Yiping; Alston, Marc; Richardson, Anita F (CBER); Stockbridge, Lisa L

Subject:                 RE: Request for Compliance Check (Kedrion Biopharmaceuticals, SpA, BLA 125384/0), Action Due 6/3/11

Firm:
Applicant: Kedrion, S.p.A.
Address: Loc. Ai Conti
55051 Castelvecchio Pascoli
Barga (Lucca), Italy
[NOTE: This is the address of Kedrion's headquarters, the production facility address is listed below]
US License Number (if any):   None
FEI#: none identified to date
 
Kedrion Biopharmaceutical, S.p.A
Via Provinciale
Bolognana, Gallicano (Lucca)
Italy 55027
FEI# 3008919567
 
STN #: BLA 125384/0
 
Summary: Kedrion Biopharmaceuticals, S.p.A. is seeking licensure for their 25% Human Albumin Solution (intravenous). This will be Kedrion's first licensed product sold in the US. Kedrion was inspected by DMPQ and OBRR in February 2011 and it was the first ever inspection of the facility.
 
A Pre-approval inspection (PAI) of Kedrion Biopharmaceuticals, S.p.A. was conducted February 23-25, 28 and March 1-2, 2011 and classified as Voluntary Action Indicated (VAI). The inspection was endorsed on May 31, 2011 and final closeout memo is dated May 31, 2011. Therefore, the Office of Compliance and Biologics Quality, Division of Case Management does not object to the approval of this supplement. Therefore, the Office of Compliance and Biologics Quality, Division of Case Management does not object to the approval of this supplement.
 
Kimberly A. Cressotti, CSO
CBER/OCBQ/DCM/HFM-624