FDA Dismisses Novo Nordisk Inspection Concerns
FDA has taken the unusual step of issuing a statement about recent agency inspections at Novo Nordisk’s Clayton, NC manufacturing facility to quell concerns about any quality issues involving products made there. Standard operating procedure for FDA is to not make any direct statements regarding recent inspections and any ongoing investigation, particularly when public safety is not being compromised.
Earlier this week, many news outlets, including FDA Webview (see story), reported on a recent inspection that resulted in a two-item Form FDA-483 that cited GMP deficiencies at the manufacturing plant, which is a key facility for making its diabetes and weight-loss drug semaglutide (trade names Ozembic and Wegovy). Novo Nordisk has declined comment other than saying the facility was “running and producing for the market.” There has been increased demand for Ozembic and Wegovy, and FDA’s drug shortage list has several Wegovy dosages and one Ozempic dosage shown.
On 9/21, an FDA spokesperson emailed FDA Webview the following statement:
As part of the FDA's normal operations, FDA investigators have conducted pre-approval and routine inspections of the Novo Nordisk Pharmaceutical Industries LP facility in Clayton, N.C. Following these inspections, FDA investigators have issued Form FDA-483s describing observations made during the inspections of the site. The company responded to these observations with information describing corrective actions. At this time, based on the FDA’s inspections and the company’s responses to the inspectional observations, the FDA does not have information that suggests ongoing compliance issues that raise concerns about the quality of drug products manufactured at the site.
The second inspection that FDA is acknowledging in its statement occurred 5/2022 and detailed quality control lapses at the North Carolina plant, according to Reuters, which obtained the FDA-483 under a Freedom of Information Act request. The issues were related to the facility’s control systems to prevent microbial contamination, the same as those cited in the more recent inspection this July, the news service says.
The 2022 inspection report shows that FDA investigators found the facility failed to include “B. cepacia” on its list of “objectionable organisms,” Reuters says, adding that two laboratory investigations in 2020 and 2021 found drug product samples containing the bacteria. Novo Nordisk was also cited for: “Failure to clean equipment at appropriate intervals” to prevent build-up of microorganisms on equipment. The FDA-483 noted that the equipment in question was used for “continuous production” of active pharmaceutical ingredient batches. “When inspectors returned to the facility in July, they found that although the site was identifying objectionable organisms during testing of batches of semaglutide API, it had failed to thoroughly identify the cause of the bacteria present in these batches,” Reuters reports.
Meanwhile, Reuters indicated that financial analysts and manufacturing experts interviewed dismissed the inspections as being critical to the ongoing manufacturing of semaglutide at the facility.