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FDA 'concerned' after inspection of China heparin plant

By Kirsty Barnes , 04-Mar-2008

The US Food and Drug Administration (FDA) has alerted the media to the preliminary findings of its inspection of the Chinese facility that supplied the active pharmaceutical ingredient (API) for Baxter's heparin - now recalled from the market after a safety scare.

FDA spokesperson Karen Riley said that the agency's inspection team has completed their inspection of the China facility and a "number of potentially objectionable conditions" were identified relating to the firm's manufacturing process.

 

 

 

She did stress, however, that no conclusions can be drawn yet as to the cause of the adverse events: "…at this time we still have not identified a root cause… we're still evaluating this inspectional work product and working to determine the level of significance associated with these observations," said Riley, who also confirmed that for the time being, the facility has currently stopped manufacturing.

 

 

 

Giving a little more detail, the FDA said that the teams' inspectional observations related to deficiencies in the plant's evaluation of the steps it takes to remove impurities; its investigation of out of specification results; issues related to waste material flow; and deficiencies related to equipment.

 

 

 

"It's important to note that while we're concerned about what we have observed, we aren't at a point where we can determine any links between the observations and the adverse events seen in association with Baxter's drug products," the agency reiterated.

 

The teams' inspection observations were recorded as a list of inspectional observations, called Form 483, which is a report of potential deficiencies.

 

 

 

The FDA said that the document is presented to the company once a plant inspection is complete and when objectionable conditions are observed. A redacted version of this form will also be posted on the FDA website shortly.

 

 

 

"We view a 483 as just one step in the inspection process. The complete inspectional work product includes the inspection report, the exhibits, the evidence and sample analysis results. And it is this entire package that the agency uses as well as any of the firm's promised corrective actions to make a final decision about the compliance status of a facility. This process is underway," the agency said.

 

 

 

The identity of the Chinese plant in question has been revealed as Changzhou SPL, a factory in the city of the same name. This facility is actually 55 per cent owned by Scientific Protein Laboratories, the company that also supplies the heparin API from a site in Wisconsin, US.

 

 

 

The FDA has conducted an investigation at both of these plants, as well as a facility owned by one of Baxter's subsidiaries in New Jersey, where the finished heparin is packaged.

 

 

 

Baxter recently suspended the production of its blood-thinning drug heparin in multi-dose vials, following the deaths of four patients in the US who were given the drug in high doses, along with 350 reports of severe allergic reactions to the drug, with symptoms including a rapid drop in blood pressure, burning sensations, headaches, throat swelling and a shortness of breath.

 

 

 

Meanwhile, the investigation surrounding the recall is starting to widen: "Our team remains in China and is continuing their investigation at other facilities that have a relationship to the API manufacturer," the FDA said.

 

 

 

The API for heparin is originally derived from pig intestines, and so there are a number of firms that are relevant upstream from the manufacturing process that the agency said were of interest to its investigation.

 

 

 

"We're working with the Chinese government as well as the company to try to understand the records associated in identifying these workshops and other farms."

 

 

 

"Subsequent actions may include further investigation of involved facilities, sample analysis by the FDA and involved companies and a complete study of the adverse events and any other information that becomes available."

 

 

 

Upon completion of the investigation, the FDA said it will undertake any appropriate regulatory action.

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