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Regulatory Focus™ > News Articles > 2019 > 10 > FDA Warns Massachusetts PET Drug Manufacturer

FDA Warns Massachusetts PET Drug Manufacturer

Posted 29 October 2019 | By Zachary Brennan 

FDA Warns Massachusetts PET Drug Manufacturer

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Woburn, Massachusetts-based PETNET Solutions Inc. after an inspection last spring uncovered unclean conditions and failures in environmental monitoring for the positron emission tomography (PET) drug manufacturing site’s aseptic operations.

The letter notes that the FDA inspector “observed a state of disrepair and lack of cleanliness” at the site, while “sporeforming fungi were repeatedly identified in the ISO 8 area.”

In 2017, for instance, the company “had a sterility test failure for a batch of Fludeoxyglucose (FDG) F18 injection. You identified the microbial contaminant as the sporeforming bacteria, Brevibacillus limnophilus,” FDA said, noting that significant trends of sporeforming organisms continue.

“Over approximately three years, you failed to adequately respond to data indicating insufficient microbial control in the areas where you conduct aseptic manipulations, as well as adjacent areas,” the agency added.

FDA further explains in the letter how PET drug manufacturing requires vigilant environmental control and appropriate attention to microbial recovery in ISO 5 areas. And the agency notes that one of the company’s operating procedures for sterility testing lacks details on disinfecting and flow of testing supplies between unclassified and ISO 5 areas.

FDA also calls on PETNET, which is a Siemens subsidiary, to bring in a CGMP consultant for help and to comprehensively assess other manufacturing facilities within its network.

A Siemens spokesperson told Focus: "PETNET Solutions takes this matter very seriously and is working with the FDA to promptly address the agency’s concerns. In addition to high delivery reliability, we maintain stringent quality processes to meet the needs of our imaging center customers, their patients, and referring physicians, and we remain committed to the safety and well-being of those patients."

Warning Letter

Updated on 10/30 with comment from Siemens.

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