Following an inspection by the US Food and Drug Administration betweenNovember 28 and December 4, 1996, UK drugmaker Zeneca last month received a warning letter relating to its production facilities at Macclesfield, UK, where the company's anticancer drug Zoladex (goserelin) is made.
The warning letter relates specifically to a "technically-demanding sterile manufacturing process," according to Zeneca, which adds that the safety and efficacy of Zoladex, which has been manufactured in Macclesfield for 11 years, is not under investigation, and its manufacture, supply and use is unaffected by the FDA warning.
Zeneca notes that it has met with FDA officials in Washington DC, and is in the process of responding to the points made in the warning letter. It says it "is confident that the issues raised can be addressed to the satisfaction of the FDA."
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