in this issue
World News and Views :: Top of the News
FDA Issues Warning Letter to Merck KGaA’s API Plant in Switzerland
5:50 AM MST | February 16, 2012 | Deepti Ramesh
The U.S. Food and Drug Administration (FDA) issued a warning letter in December 2011, to the active pharmaceutical ingredient (API) facility at Corsier-sur-Vevey, Switzerland, of Merck KGaA’s Merck Serono (Geneva) division, for deviating from current good manufacturing practice (cGMP). The FDA published the warning letter on its website, earlier this month. An FDA inspection of the Corsier-sur-Vevey API facility from June 1-June 9, 2011, identified significant deviations from cGMP for the manufacture of APIs and significant violations to requirements...
This information is only available to Chemical Week subscribers.
Forgot your user ID or password?
Not an IHS Chemical Week member yet?
Here's why you should be:
100% Satisfaction Guarantee