The FDA hit Amgen with a warning over drug/device combo manufacturing violations

California biopharmaceutical giant Amgen ($AMGN) got smacked with an FDA warning letter alleging quality system manufacturing violations in some of its drug/device combo products. These prefilled syringes and related devices are prepped for osteoporosis and autoimmune treatments.

Specifically, the citation targets prefilled syringes and related devices paired with Prolia, Amgen's osteoporosis drug, and Enbrel, a drug to treat autoimmune diseases that Amgen co-markets with Pfizer ($PFE).

The FDA, in its January 27 letter, contends that Amgen lacks procedures in place to make sure the devices designed to deliver both drugs were properly vetted or designed to meet users' needs. Regulators also cite the company for not making sure that suppliers, contractors and consultants meet the appropriate standards for their roles in the production process, among other alleged violations.

Amgen's warning letter is based on an inspection of its Thousands Oaks, CA, facility from June 4 to June 17, 2013. Amgen responded to initial concerns from FDA inspectors, but the agency said those responses weren't enough.

Amgen's course of action could temporarily reduce the amount of drug-device combo products it produces for both treatments. The FDA said it wants adequate notice if that happens, so it can address potential drug shortages such an action could create, and also address the manufacturing process concerns as quickly as possible.

The company has 15 days from the date it receives the warning letter to outline steps it has taken to address violations, as well as the steps it will take to prevent future ones.

Amgen issued the following statement in response:

"Amgen takes these issues very seriously and we have implemented changes to our procedures. We are committed to working with the FDA to take appropriate measures and provide the necessary information to address the concerns raised in the letter."

- here's the full warning letter

Editor's note: This story has been updated to include a statement from Amgen.

Suggested Articles

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.

Akoya Biosciences raised $50 million to help boost its commercialization in research, drug development and clinical testing markets.