Novartis ($NVS) appears to be having a tough time getting its act together as far as the FDA's view of manufacturing standards go.
The company's Sandoz unit reported last week that production of some of its drugs at a plant in Boucherville, Quebec, Canada, had been suspended because remediation efforts there required it stop production lines. Novartis Consumer Health is still grappling with issues at a plant in Lincoln, NE, that was closed because of a long list of FDA observations.
In a letter to customers, Sandoz said the company "has been working diligently to improve quality operations across all manufacturing sites," but because of "issues raised by the FDA, Sandoz Canada has expanded the remediation actions already [under way] and has opted to discontinue certain products and temporarily suspend the production of other injectable products."
The suspension will allow the company to focus on sterile injectable production and the supply of critical injectable medicines, it said.
To do that, the Quebec plant has stopped making "ointments, ophthalmics and suppositories, as well as all non-medically necessary injectable drugs." Sandoz suggested this might result in short supplies of some drugs "requiring customers and [healthcare] practitioners to adapt their treatment regimens accordingly." The company emphasized the suspension does not affect its solid oral product line sold in Canada. Furthermore, neither its patches nor Omnitrope, which is used to treat children with growth hormone deficiency, is affected.
"[W]e will make every effort to meet medical needs while ensuring consistent high quality standards across our manufacturing operations and the ongoing improvement of our processes," its missive to customers said.
This all sounds very familiar. Novartis recently said it was working to address FDA issues in Nebraska and was committed to "ensuring the highest standard for consumers who rely on our products."
According to the FDA report about the Lincoln operations, the plant was lax about maintenance, short on staff and training, and complacent about some aspects of quality control that on many occasions led to the wrong drug showing up in containers. Among others, there were reports of Excedrin Migraine tablets also containing Excedrin caplets and regular-strength aspirin in an Excedrin Migraine geltabs carton. The report said that as of Dec. 12, there were 1,360 unresolved consumer complaints.
The plant was tied to recalls of Novartis over-the-counter products, including its entire Excedrin line. The plant also made painkillers for Endo Pharmaceuticals ($ENDP), which has been affected by the closure.
- check out the Sandoz letter (.pdf)