Boehringer held up by FDA for production violations
pharmafile | May 24, 2013 | News story | Manufacturing and Production | API, Boehringer, FDA
Boehringer Ingelheim has pledged to resolve manufacturing compliance issues at a facility in Germany uncovered by the US Food and Drug Administration.
An inspection of the plant in Boehringer’s home town of Ingelheim last November found a number of deviations from Good Manufacturing Practice (GMP), including a failure to properly investigate ‘critical deviations’ in the manufacturing of active pharmaceutical ingredients (APIs).
The findings – and what the DA said was an inadequate response by the company – prompted the FDA to send Boehringer a warning letter earlier this month giving it 15 days to respond with a remediation plan.
Among the violations uncovered during the inspection was a failure to investigate contamination of APIs with foreign particles, with batches of API subsequently passed and used in the manufacture of finished products.
“We are concerned about your inability to prevent the presence of foreign particles in your APIs and the adequacy of actions taken to address the situation,” says the letter.
The company has also been upbraided for failing to reject finished drug products – including a lot of its chronic obstructive pulmonary disorder (COPD) treatment Spiriva (tiotropium) – that did not meet quality criteria including contamination with foreign particles. The Spiriva lot was subsequently recalled, but only after it failed 12-month stability testing.
Boehringer has been wrestling with other quality issues in its manufacturing network, but these have focused mainly in its US contract manufacturing subsidiary Ben Venue Laboratories, which was forced to stop production at its plant in Bedford, Ohio, in November 2011 and is currently operating under a consent decree with the FDA.
Gerhard Koeller, head of corporate division quality at Boehringer, said the firm “will invest all our energy to remedy the situation in order to meet all FDA requests” and ensure that it “implements corrective and preventive actions to optimize its quality systems”.
Phil Taylor
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