FDA hits Spanish drug substance maker Bioiberica with a Form 483

The FDA is citing Spanish drug materials maker Bioiberica for a number of manufacturing issues, which are outlined in a Form 483.

The facility, which is located in Palafalls, Spain, was inspected by the regulatory agency between Jan. 31 and Feb. 4. During the visit, the FDA found issues with microbiological contamination and improper cleaning procedures.

The company was called out for five observations that included a lack of established control procedures for monitoring the output manufacturing processes, which could potentially cause variability in the drug substance.

Of particular concern for the FDA were written records regarding investigations into previous discrepancies about an unnamed drug. Those records didn't reach conclusions that would have required follow-up procedures.

In a statement, Bioiberica's CEO Luis Solera said the company takes FDA feedback "extremely seriously."

"We have taken swift action on this matter and are in close communication with the FDA to ensure it is satisfied with the steps we are taking to resolve the concerns raised in its observations, as quickly and effectively as possible,” Solera added.

Bioiberica’s quality control unit was also cited for procedures or specifications around identity, strength, quality and purity of substances and not having a written testing program to assess the stability characteristics.

The observations relate to thyroid active pharmaceutical ingredient manufacturing, Bioiberica's R&D and quality director Javier Velasco, Ph.D., said in a statement. In its write-up, the FDA didn't flag any other active pharmaceutical ingredients made at the site.

The company produces products for animal, plant and human health, according to its website.

Editor's note: This story was updated with statements from Bioiberica executives.