The facility in question, which is located in Milan and was acquired in 1994, makes a wide range of generic APIs, supplying pharmaceutical manufacturers in key markets like the US, Japan and Europe.

New Jersey based Cambrex said the warning relates to observations about “the collection and maintenance of certain laboratory data” following a Food and Drug Administration (FDA) inspection of the facility that took place in March.

The firm went on to explain that the FDA may withhold approval of generic APIs made at the plant and block their importation into the US until the observations are resolved.

Cambrex is confident it can resolve the issues in the allotted time. However, any extra delay may hurt its generic API business which, according to CEO Steven Klosk, already faces price and volume pressures due to “competitive supply chain dynamics.”

The firm will also hope that the FDA warning letter does not impact on plans to launch two new generic APIs next year, which were announced at its second quarter results presentation earlier this month.

Although the FDA has not yet published the warning letter, the threat of an import ban will be taken seriously given the similar action the agency has taken against a number of generic producers in the last 12 months.