EXCLUSIVE - FDA finds lapses at Novo's main US factory in May 2022 - report

Written by Maggie Fick

LONDON (Reuters) – U.S. drug regulators launched a report detailing high quality management lapses at Novo Nordisk’s major North American plant as early as Might final 12 months, based on the report obtained by Reuters by means of a Freedom of Data Act request.

The inspection was carried out by the US Meals and Drug Administration (FDA) at Novo’s facility in Clayton, North Carolina, which the corporate says produces the energetic pharmaceutical ingredient (API), semaglutide, used within the standard weight reduction drug Wegovy and the sort 2 diabetes drug Ozempic.

There is no such thing as a proof that the compliance failures reported within the report often called Kind 483 resulted in hurt to Wegovy and Ozempic customers. Kind 483 is a kind of company report that incorporates “observations” that FDA inspectors take into account “objectionable.”

The problems have been associated to the plant’s management methods to forestall microbial contamination, the identical points raised within the final inspection final July, which was first reported by monetary information company MarketWire and despatched Novo shares down 3%.

Novo declined to touch upon the Might 2022 report.

A spokesperson referred Reuters to the corporate’s assertion on Monday, responding to the US Meals and Drug Administration’s report from its July inspection, that the Clayton web site was “working and producing for the market.”

The Meals and Drug Administration didn’t instantly reply to a request for touch upon the report, but it surely doesn’t sometimes touch upon inspections.

One business professional, who spoke on situation of anonymity due to the sensitivity of the matter, stated related points in two inspections at one cut-off date might expose the positioning to higher scrutiny by the FDA sooner or later.

A Might 2022 inspection report reveals that FDA officers discovered that the plant failed to incorporate one species of micro organism, abbreviated as B. cepacia, on its record of “objectionable organisms.”

The report said that two laboratory investigations performed by the manufacturing unit, in 2020 and 2021, discovered samples of pharmaceutical merchandise containing this explicit micro organism.

The report included a second manufacturing lapse: “failing to wash tools at acceptable intervals” to forestall the buildup of microorganisms on the tools. The report famous that the tools in query was used for “steady manufacturing” of batches of API.

When inspectors returned to the power in July, they discovered that though the positioning was figuring out undesirable organisms whereas testing batches of the semaglutide API, it had didn’t precisely determine the reason for the micro organism in these batches.

Analysts at Barclays and Jefferies stated in notes this week that whereas traders could also be involved by information of potential manufacturing points, they noticed little impression on Novo’s manufacturing of semaglutide.

Stephen Lin, former head of the FDA’s Workplace of Manufacturing and Product High quality who now works as a regulatory compliance guide, stated that though the subject material in each inspections is identical, it’s not truthful to say that the newest inspection reveals the manufacturing unit didn’t right the lapses it found. Inspectors final 12 months.

“It seems that (the manufacturing unit) has enhanced the record of objectionable organisms, however now they don’t seem to be adequately investigating instances after they determine an objectionable object,” he stated.

Different manufacturing consultants say the FDA pays shut consideration as to if loopholes recognized within the company’s earlier inspections have been fastened as a measure of whether or not an organization is carefully adhering to good manufacturing rules.

(Reporting by Maggie Vick; Modifying by Josephine Mason and Mark Potter)

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