FDA Documents Reveal cGMP Issues At Novartis Plant Where Cancer Drug Production Was Stopped

FDA Documents Reveal cGMP Issues At Novartis Plant Where Cancer Drug Production Was Stopped

June 3rd, 2022 // 6:39 pm @

In May, Novartis took the unusual step to stop production of two cancer therapies that rely on nuclear medicine to target various cancer cells. They also stopped clinical studies for one of the cancer treatments.

Novartis said at the time that it was taking the step to be cautious to deal with possible cGMP issues that were found in its drug manufacturing processes at several drug plants in Millburn, New Jersey as well as in Italy. The company didn’t provide more explanations. But a spokesman for the company said FDA regulators cited the firm in a 483 issued in fall 2021 for their NJ plant.

It’s hard to say how much the QC problems FDA found contributed to the call to stop drug production. But the issues FDA raised, the subsequent responses from the company, show there have been several drug production problems with Novartis recently.

Novartis was on the back foot after the agency inspected its New Jersey facilities over several weeks last fall. FDA issued a 483 and the document revealed several serious cGMP problems.

One of the most serious problems was Novartis didn’t tell customers about Lutathera batches that were sold even though they did not meet QC standards. Lutathera is given to patients to treat endocrine gland tumors. The other drug with QC problems was Pluvicto, which is for treating prostate cancer.

In the FDA document, the agency noted the company has procedures that lets them ship sterile injectable drugs that are under quarantine before QC and tests are done. But FDA said this method doesn’t ensure the products are of high quality before they are shipped. Also, there wasn’t evidence that drug customers were told to make sure the drugs were not given to patients.

However, Novartis was unhappy with this observation. In a December response, Novartis noted that 11 of the 16 drug batches were rejected before they were shipped. And the other five were rejected when they were being shipped and prior to delivery. So, Novartis said it didn’t need to tell customers and none of the drugs were given to patients.

However, the company admitted that it could have been better with its CAPA procedures. It also admitted that it did not investigate several instances where gloves that were worn by workers could have had holes, which can affect sterility.

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