Fresenius Slammed With Warning Letter for Complaint Handling
August 26th, 2013 // 12:25 pm @ jmpickett
Latest FDA and cGMP Compliance News
FDA has issued another warning letter to the German health care company Fresenius, telling it to improve various cGMP procedures at its plants. This time the plant in the crosshairs is a blood bag making facility based in Puerto Rico.
The warning letter from FDA hit the company for its poor complaint-handling procedures and its labeling at the site in Puerto Rico. The company says that no patients have been put at risk, but getting a warning letter about your complaint handling is not a sign that all is well in that area. Fresenius is saying also that it is fully addressing the warning letter issues and that the plant is continuing to produce. It noted also that its full year earnings are on target for its infusion drugs and blood transfusion products.
Last month, the company got a warning letter that was related to an audit of its cancer drug facility in India. Also, in March, the company’s subsidiary named Fresenius Medical Care, which is the world’s biggest dialysis company, was informed by FDA that it needed to improve how the firm is sterilizing some dialyzers for filtering the blood of patients.
In June, Fresenius Kabi recalled voluntarily some benztropine mesylate and magnesium sulfate injections in the US because of the risk of glass particles being in some vials.
Problems with complaint-handling procedures are extremely common, and FDA often gives out warning letters and 483s for easily-avoided problems with handling complaints. For more information about how to set up an effective complaint handling system, please review our upcoming Webinar, The Essentials of Complaint Handling and Post Marketing Management.
