An FDA official says the failure to inspect the Chinese plant that produced the active ingredient in Baxter’s Heparin was due to a mistake in paperwork placed in the agency database. The name on the Heparin application was incorrectly forwarded to the FDA Office of Compliance, prompting the agency to review a different plant than Changzhou SPL, which supplies Baxter, according to Joseph Famulare, deputy director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

“This facility is an isolated instance right now,” Famulare says in a teleconference call with the media. “It was not the correct firm named in application…We’ve discovered that, we’re acting upon that. We’re looking at this process and not found other firms in this category…it was the wrong firm put into the database… we’re still in the process of studying this situation….we’ve looked at this and discovered this within the past month.”

His remarks come amid growing concern over FDA supervision of foreign plants, especially in China, that make or supply key ingredients for prescription meds sold in the US. Baxter’s Heparin has been linked to hundreds of adverse reactions and four deaths in the US, but Changzhou wasn’t licensed by China’s drug regulators to make pharmaceutical products, and the FDA last week acknowledged it never inspected the plant either. Changzhou is largely owned by Scientific Protein, which is based in Wisconsin. Baxter halted production multiple-dose vials of the injectable blood thinner last week.

Despite what Famulare described as an error, he insisted that FDA policy is to inspect all facilities that are named in applications for drugs for which marketing approval is sought in the US. “If an API (active pharmaceutical ingredient) is named in the application, FDA will inspect it prior to approval of the application….” he says, adding that the facility supplying the key ingredient to APP Pharmaceuticals, which is attempting to fill the void caused by the disruption in supplies from Baxter, has been inspected.

UPDATE: At 7 pm EST, we clarified the first paragraph to make clear the mistake was caused by the way the info on the application was submitted to the FDA database, not to the FDA itself by the company.