Heparin Supplier Warned by FDA... Again
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
After being sent an inspection letter by the FDA back in the fall, Scientific Protein Laboratories has been sent a warning letter by the FDA for failing to consider widening its investigation into contamination of other lots of Heparin after the recall in 2007 and 2008 of contaminated Heparin from China. The FDA wrote:
"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. The manner in which you addressed this problem is very worrisome with respect to the timeliness of the investigation, the identification of all potentially affected drugs, and implementing appropriate actions to resolve the issues."
The FDA has told SPL to investigate whether or not additional lots of Heparin needed to be recalled. They were notified in October of 2008 and their investigation didn't begin until September 2009. They ended up finding more contaminated Heparin in May of 2010 but didn't recall it until October of 2010.
Recently there has been legislation in Congress to increase funding to the FDA to help prevent the Heparin situation from ever happening again. Until regulators are able to monitor more facilities, and in particular facilities overseas, it may be a impossible to have companies properly regulated and monitored.