Baxter Healthcare Facilities Cited For Multiple Violations by the FDA
The FDA has sent Baxter International a warning letter laying out problems it found during inspections at a plant in North Carolina and in Jayuya, Puerto Rico. Previously, both the Puerto Rico and North Carolina locations have had violations during FDA inspections. The North Carolina plant had violations first noted in August of 2012 while the Jayuya plant was first cited on January 11, 2011. During the most recent inspection, the FDA found similar observations and problems that were found as in the previous inspections.
The May 31, 2013 letter lays out a number of issues at the plant in Marion, NC. These problems include mold accumulating over filling lines. Baxter stopped its line and halted release of products but never figured out the root cause that allowed the mold to grow to a level of that was too numerous to count.
According to the FDA May 31, 2013 letter, the North Carolina facility additionally:
“…failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards· of identity, strength, quality, and purity (21 CFR 211.160(b).”
Among problems uncovered at the Puerto Rico plant, the FDA said the company found issues with leaky bags on 39 lots. Baxter put a hold on 25 of them but had no plan for dealing with the 14 that had already been released into the market. The FDA also said Baxter reported 20 nonconformance reports on liquid products containing everything from skin to human hair to rayon and that there was no indication that its processes were sound enough to prevent the problem on an ongoing basis. The Jayuya plant was cited two years ago in a warning letter for failing to investigate batch failures.
Baxter is now required to notify the FDA within 15 days of “the specific steps that you have taken to correct and prevent the recurrence of violations, and provide copies of supporting documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections”.
Baxter develops, manufactures and markets health products. It is no stranger to litigation, currently a defendant in over 750 cases in connection with the recall of heparin. The first verdict in the case was for the estate of a man who his attorneys say was given a dosage of a blood thinner made by Baxter International Inc. In early 2009, samples of viral material supplied by Baxter International to a series of European laboratories were found to be contaminated with live Avian flu virus.
On July 2, 2009, Kentucky Attorney General Jack Conway announced a settlement between the state and Baxter Healthcare Corporation, a subsidiary of Baxter International, worth $2 million. The company had been inflating the cost of the intravenous drugs sold to Kentucky Medicaid, at times as much as 1300%.
In 2010, a jury in Las Vegas, Nevada ordered Baxter to pay $144 million to patients who had been infected with Hepatitis C after doctors wrongly reused dirty medical supplies to administer propofol to patients.
In December 2011, the non-partisan organization Public Campaign criticized Baxter for spending $10.45 million on lobbying and not paying any taxes during 2008–2010, instead getting $66 million in tax rebates, despite making a profit of $926 million.