FDA has issued a Warning Letter to Hameln Pharmaceuticals GmbH after observing “significant” cGMP violations for finished pharmaceuticals at the company’s facility in Hameln, Germany. The letter, dated Dec. 17 2012, was posted on FDA’s website earlier this week.
The Warning Letter relates to an inspection conducted in June 2012. FDA observed several violations including a lack of education, training and experience for specific tasks. As an example, FDA says that one employee examining plates was unable to read and accurately record microbial counts. Employees involved in sterile filling operations were also not following procedures, such as glove-change frequency, the handling of dropped objects, personnel monitoring and sample acquisition.
Since the inspection, Hameln has issued several responses to FDA. Although the company has retrained employees, however, FDA wants to know why the company was unable to identify and mitigate the lapses in the first place.
FDA also noted a lack of (or inappropriately followed) written procedures designed to prevent microbial contamination of sterile drug products, citing that FDA smoke study videos were not sufficient to evaluate Class A airflow. Hameln has provided a written evaluation of the studies, but FDA is not convinced and has asked for additional evidence or a repeat of smoke studies.
Another observation of the FDA was Hameln’s failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas. For example, FDA said, “There was no justification for the failure to place nonviable probes in locations related to the risk of exposed containers and product.” FDA also claims that nonviable probes were in locations that provided information of little value in terms of monitoring how environmental conditions may impact the product.
In one of its responses, Hameln explained that one of its restricted barrier system units is difficult to use and that the company would redesign it by March 31, 2013. FDA has asked the company to explain the risks that may have occurred when producing previous batches with the old design, as well as risk-mitigation efforts.
FDA also added that inspectors observed additional violations, which are not detailed in the letter.