Heparin Deaths

A different wrongdoer, but so many similar complaints to what the FDA found wrong with Baxter/SPL’s production of Heparin. Here is the second part of the FDA warning letter to Qingdao Jiulong Biopharmaceuticals Co. Ltd. Like Chanzghou SPL, insufficient quality review was pervasive.

2. Failure to conduct and document regular product quality reviews for the drugs produced that would include at a minimum, a review of your critical in-process controls and test results; review of all batches that failed to meet the established specifications; and investigation of process deviations and complaints to ensure your product remains within specifications and that corrective actions have been implemented.

In a letter sent to your attention on September 29, 2008, we informed you that your written response to the FDA-483 of August 13, 2008 was found deficient and lacked specific information related to the responsibilities of your quality control unit. In your letter of November 07, 2008, you acknowledge our concerns regarding the failure to perform product quality reviews by committing to perform Annual Product Reviews. You indicate that most of the product review activities were documented as part of your annual internal auditing reports. However, during the inspection, the investigators noted that your annual internal reviews involved only completing a check box document. This product quality review is inadequate in that it lacks adequate content or information, such as explanation of all deviations from established procedures and outcome of 
investigations of critical deviations.
Although in your response of November 7, 2008 you include a new SOP specifying that “Annually, QA shall perform annual quality review on all products manufactured, distributed and marketed by the Company,” the corrective action implemented is inadequate. We are concerned that you have only committed to conduct an “annual product review for product lots produced during 2008.” As you are aware, 19 lots of heparin sodium manufactured at your facility during 2007 and shipped to the U.S. were found contaminated with OSCS.

Please include in your response a copy of complete product quality review reports covering the manufacturing of heparin sodium for all lots that remain within expiration. Include the following:

• A review of all critical in-process controls and critical test results. 
• A review of all batches that failed to meet established specifications. 
• A review of all critical deviations or non-conformances and related investigations. 
• A review of any changes carried out to the process or analytical methods. 
• A review of the stability monitoring program. 
• A review of all quality-related returns, complaints (formal or informal from all customers) and complaints. 
• A review of adequacy of corrective actions implemented (also include the conclusions).

OSCS again. Is there a common thread here?

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Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

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