A Spanish API maker was criticized in an FDA warning letter for poor cleaning procedures, as well as for issues with equipment that was repaired with materials the agency said might actually affect the quality of its APIs.
The warning letter to Interquim, a division of Ferrer HealthTech, was filed by the FDA this week and follows an inspection at its Barcelona plant in May.
The first of the three observations faulted the facility for its cleaning processes, saying that inspectors found drug residue on equipment that reports indicated had already been cleaned. The FDA pointed out that when residue is left, there is a risk of “cross-contamination” of APIs that are later manufactured on the same equipment.
Additionally, the FDA cited Interquim for having done repairs to the interior surfaces of two non-dedicated pieces of equipment with material that the company had failed to demonstrate would not affect API quality.
Finally, the FDA warning letter said the company did not provide stability data to support the retest period it had assigned to reprocessed APIs, which the FDA said could “affect the quality of the drugs that your customers manufacture from your API.”
The FDA recently took aim at a Dutch company in warning letter for its lack of cleaning standards. The letter, filed in October against Delarange Cosmetics & Healthcare of the Netherlands, said the company’s poor cleaning procedure put its drug at risk for contamination.