SPL Statement Following Receipt Of A Warning Letter From The FDA Regarding Recent Inspection Of Facility In Changzhou, China
We regret FDA's decision to send a Warning Letter to Changzhou SPL, and we do not believe that the Warning Letter reflects Changzhou SPL's actual state of compliance with current good manufacturing practices (GMPs) in the heparin Active Pharmaceutical Ingredient (API) industry, or the positive findings in prior third-party audits of the facility. The Warning Letter repeats some of the agency's inspectional observations. Changzhou SPL already has provided a comprehensive response on these issues.
For example, the letter reiterates the observation as to the use of an unauthorized supplier, an allegation that Changzhou SPL believes already has been disproven conclusively in its 483 response. Changzhou SPL is committed to cooperating with FDA and will promptly provide a detailed response to the Warning Letter.
As FDA has previously acknowledged, there is nothing in the observations made in the Form 483 or Warning Letter that would have caused or contributed to the presence of the contaminant at issue in heparin products.
The contaminant found in certain lots of finished heparin product was not introduced in the manufacturing processes at Changzhou SPL or SPL. Based upon testing of crude heparin materials and reports from other manufacturers around the world, it is now clear that the suspect contaminant was introduced earlier in the supply chain in China and was widespread throughout the unrelated Chinese supply chains of many companies. Moreover, FDA has made clear that the contaminant in question appears to pass all prior manufacturing controls and testing requirements for heparin manufacture. SPL and Changzhou SPL continue to work actively with the FDA to identify the root cause of the contamination.
It is important to note that the Warning Letter does not relate to SPL's Waunakee, Wisconsin facility, which has maintained an exemplary inspectional record over 30 years of heparin production.
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