SPL receives warning letter for heparin quality control

The fallout from the contaminated heparin scandal continues to be felt, with active pharmaceutical ingredient company Scientific Protein Laboratories receiving a warning letter from the US Food and Drug Administration (FDA) last month relating to its part in the affair.

According to the letter, SPL failed to carry out a proper investigation into a complaint from a customer about possible contamination with oversulphated chondroitin sulphate (OSCS), which was responsible for deaths and serious side effects among patients and led to massive recalls of heparin products around the world.

Although the complaint was received in October 2008, SPL did not follow it up for almost a year, says the FDA, which sent the warning on the back of inspections of SPL's manufacturing facility in Waunakee, Wisconsin, between July and September 2010.

SPL also waited around eight months before extending its investigations to other lots of heparin sodium USP manufactured using the same crude lot imported from China which was OSCS-contaminated, says the letter, addressed to SPL president and chief executive David Strunce.

The company has closed down a manufacturing facility for heparin in China and now produces all its heparin API from the Waunakee plant.

"Your handling of the heparin contamination complaint suggests the need to evaluate training across all departments about the types of information requiring prompt reporting to the quality unit," according to the FDA.

Other violations detailed in the letter include a failure to audit a contract quality control laboratory properly and not having equipment for making APIs "of appropriate design for its intended use."

An investigation into the 2008 contamination incident indicated that SPL had sourced heparin from China which was adulterated with OSCS, a cheaper substance that can mimic heparin in identity testing but can cause serious allergic reactions.

The incident is believed to be a case of economically-motivated adulteration (EMA), in which ingredients are deliberately adulterated to fool lab testing and increase their value.

Meanwhile, SPL continues to fight litigation alleging that it and co-defendant Baxter International were negligent in allowing the contaminated heparin to reach patients.

Last November, a judge in a US court ruled against Baxter International in the first round of the dispute, which involves 300 consolidated cases. That judgement did not concern SPL, although the company is scheduled to face its own day in court in May.