North Carolina Thermo Fisher Plant Gets 483 For Contamination and Air Bubble Problems
October 24th, 2024 // 1:16 pm @ jmpickett
Thermo Fisher Scientific makes many important, popular pharmaceuticals for the US market, such as Wegovy, an obesity drug, and Beyfortus, a product that treats infant respiratory syncytial virus. However, FDA recently inspected the firm’s plant in Greenville, NC, and found several issues.
FDA inspected Thermo Fisher’s 1.5 million square foot facility run by its Patheon CDMO subsidiary. The plant handles sterile dose manufacturing and filling and has at least 1,500 workers.
Reuters recently noted that the FDA audit was part of a bigger Thermo Fisher audit that was regarding the making of Beyfortus. During the inspection, FDA found several problems in many areas. first, the facility had issues with several production procedures. One of them was measuring and monitoring bubbles of air that appeared in syringes.
FDA states in its report that the sampling plan for bubble size didn’t produce statistical confidence in the process performance. Also, the report states that some of the firm’s visual inspection processes were inadequate and were using a time frame that wasn’t supported by clinical studies. Especially important was ensuring that a finished product didn’t contain any particulate matter.
There also were concerns about microbiological contamination of several sterile drug products. Some aspects of the drugs, such as stoppers, were unsterilized before being assembled. In one instance, a stopper made contact with an unsterilized drug. FDA noted in the report that in the last three years, the plant in NC had about 35 glove integrity testing problems during its filling operations. Six of them affected undisclosed drug products. However, only one batch of product was sent out for distribution in the US.
FDA added that there were inadequate conclusions and follow-ups, which sometimes included product impact assessments in written investigation records. In one case, Thermo Fisher couldn’t ensure that syringes with air bubbles were taken from commercial batches during the drug making process. There also were several deviations that the firm investigated but root causes were not clearly identified.
Last, FDA noted several red flags in the QC unit pertaining to electronic data systems and meta data related to several batch records.
