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Posted by on Feb 28, 2008 in FDA, Pharma

Heparin Supplier Changzhou SPL: FDA Inspection Form Now Available

Heparin Supplier Changzhou SPL: FDA Inspection Form Now Available

For what it’s worth, a newly available, heavily redacted inspection form details observations made by FDA investigator Regina T. Brown and chemist Zi-Qiang Gu regarding Changzhou SPL Company Ltd, the Chinese facility that supplied some of the main ingredient in Baxter’s now-recalled heparin products.

The general impression, after attempting to read through the “whiteout,” is one of shoddy documentation and execution of heparin processing (particularly concerning the removal of impurities) and quality control at the Chinese plant.

One itemized deficiency relates to the “description of manual manipulations of the [Redacted] during processing steps.” The description continues, “[T]hey do not include the actual, manually entered [Redacted] set temperatures and times and, operator observations such as level measurements, used in calculations, during the [Redacted] step are not recorded.” Given the reference to “manually entered…set temperatures and times,” this notation may well relate to a poorly documented autoclave depyrogenation step.

bmartin (1127 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.