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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Review of Original BLA - RECOTHROM

MEMORANDUM

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality

Date: 13 December 2007
To: STN 125248/0 Thrombin (Recombinant)
ZymoGenetics, Inc. (License No. 1758)
From: Nancy Waites, Reviewer, MRB1/DMPQ/OCBQ/HFM-675
Through: Caroline Renshaw, Branch Chief /MRB1/DMPQ/OCBQ/HFM-675
Subject: Review of original BLA submitted electronically by ZymoGenetics, received 18 December 2006, for Thrombin (recombinant).

Recommendation: I recommend approval of this submission if all other review offices do not have any issues with the submission.

Review Narrative and Comments

Description:
Recombinant human Thrombin (rhThrombin) drug product is a sterile, lyophilized white to off-white solid and/or powder that contains no preservative and it is reconstituted with 0.9% sodium chloride injection, USP. Upon reconstitution, rhThrombin drug product is a clear colorless solution. It is intended for topical administration to bleeding surfaces. In various types of surgeries, solutions of rhThrombin are used in combination with an absorbable gelatin sponge, USP, for hemostasis. Solutions of rhThrombin must not be injected.

Manufacturers:

Manufacturer Address Responsibility
ZymoGenetics, Inc. 1201 Eastlake Ave East,
Seattle, WA 98102
BLA applicant:
Process development
Process validation
Methods development and validation
Shipping validation
Stability studies (rhPrethrombin-1 and BDS)
Impurity clearance studies and analytical
Support
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Complaint Returns and Recalls
Accordingly, ZGI is responsible for all product withdrawals or recalls, working under the ZGI Recall SOP -----
------------------------------------------------------

If the Product is being returned due to a product complaint, ------------------------------------------------------------------------- ZGI, will obtain the following information from the end customer returning the Product:

  • Number of units to be returned
  • Physician name
  • Fax number
  • Identify source of product (i.e. name of hospital)

------------------------------------------------------ ZGI authorization, will fax instructions for returning the Product to the end customer, which will include, at a minimum, instructions to return the Product to the ZGI designated location.

Recalls will be directed by ZGI. -------------------------------------------------------------------------------------------------- ZGI in contacting consignees and in retrieval of recalled Product and/or kits. Additionally, --- will provide the following support in the event of a recall:

  • Storage and control of on-hand inventory of recalled Product.
  • Receipt, storage, and control of returned recalled Product.
  • Documentation of recalled Product used, destroyed, or returned to the distributor through established document systems at --------------.
  • Shipment of samples of recalled Product to ZGI or a designated testing site for analysis, if applicable.

------------------------------------------------- maintains an on-site Quality Assurance/Regulatory Affairs department. This department has ------- employees who manage quality assurance, regulatory compliance and training needs. The function of this department includes quarantine, receipt, and release of product as well as day-to-day quality assurance. Training includes industry overviews as well as functional skills.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448