On August 12, FDA issued a warning letter to Novartis's Sandoz generic unit. The letter focused on manufacturing processes for a blood pressure medication. According to the letter, the manufacturing process did not undergo proper validation and FDA therefore questioned whether further distributing the product was prudent given the lack of solid process controls. The manufacturing process in question was for a generic version of Toprol XL, made by AstraZeneca.
The FDA said in its letter that it also had concerns about how the problems it found in process validation might affect other products the company has.
A spokesperson for Novartis said the company is working with FDA to address the concerns in the warning letter, which the spokesperson says were mainly about "documentation and validation."
- read the Pharmalot post
[1]- see the FDA Warning Letter here [2]
Links:
[1] http://www.pharmalot.com/2008/08/fda-warns-novartis-about-manufacturing-plant/
[2] http://www.fda.gov/foi/warning_letters/s6891c.pdf