The US regulator made the request in a warning letter today, explaining that Interquim ‘s plan to address problems with cleaning procedures identified during an inspection in May does not provide sufficient detail.
The agency acknowledged that Interquim has changed its protocols but said the firm has not demonstrated that the revised procedures are effective.
The Food and Drug Administration (FDA) also said the firm’s efforts to ensure equipment surfaces do not impact the quality of the raw materials, active pharmaceutical ingredients (APIs) and intermediates with which they come into contact with are inadequate.
The regulator also pointed out that Interquim’s quality unit had failed “to ensure that there is stability data to support retest or expiry dates and storage conditions on API and or intermediates.”
Interquim is a division of Ferrer HealthTech. The firm did not respond to a request for comment.