CBER FY 2013 Recall Postings

<!– –> <!– Page Last Updated: 03/12/2015 –> Page Last Updated: 03/12/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Package Insert and Patient Information

%PDF-1.6% 1539 0 objendobj 1558 0 obj/Filter/FlateDecode/ID[]/Index[1539 129]/Info 1538 0 R/Length 101/Prev 225307/Root 1540 0 R/Size 1668/Type/XRef/W[1 2 1]stream hbbd“b`)@DU

Biologics Guidances

<!– –> <!– Page Last Updated: 02/24/2015 –> Page Last Updated: 02/24/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Generics

<!– –> <!– Page Last Updated: 02/24/2015 –> Page Last Updated: 02/24/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Draft Guidance

FOR INDUSTRY This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA-305), Food and…

InterSol Solution/Platelet Additive Solution 3

<!– –> <!– Page Last Updated: 01/28/2015 –> Page Last Updated: 01/28/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Omrix Biopharmaceuticals Ltd Untitled Letter

March 26, 2010 – Corrected Copy FEDERAL EXPRESS Nissim Mashiach General Manager Omrix Biopharmaceuticals, Ltd Tel Hashomer Hospital Ramat-Gan, 52621 Israel Dear Mr. Mashiach: The Food and Drug Administration (FDA) conducted an inspection of Omrix Biopharmaceuticals Ltd, located at Mada Building, Tel Hashomer Hospital, Ramat-Gan, Israel, between October 21 and October 29, 2009.  During the…

CSL Biotherapies Untitled Letter

Brian McNamee Chief Executive Officer (CEO) CSL Biotherapies 45 Poplar Road Parkville, Victoria 3052 Australia Dear Mr. McNamee: The Food and Drug Administration (FDA) conducted an inspection of CSL Biotherapies, located at 45 Poplar Road, Parkville, Victoria 3052, Australia, between April 19 and April 28, 2010.  During the inspection, FDA investigators documented deviations from current…