FDA bans Zhejiang Huahai imports as valsartan review continues
- As valsartan manufacturing issues continue, the Food and Drug Administration has banned all imports of drugs and drug products from Zhejiang Huahai Pharmaceutical, which manufactured the high blood pressure medication that had a possible carcinogenic impurity.
- U.S. and European regulators have found the company's Linhai site to have manufacturing issues in the past few months.
- Zhejiang Huahai was the first company cited by the authorities for contamination of valsartan with potentially cancer-causing compounds.
The story of valsartan manufacturing issues began with Zhejiang Huahai.
In July, the FDA and European Medicines Agency supported a voluntary recall of lots of the generic blood pressure drug valsartan that contained the active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai. Regulators made that decision because contamination from the compound N-nitrosodimethylamine (NDMA) could put people taking the drug at an increased risk of cancer.
Last week, the EMA reported that an inspection, in collaboration with European Directorate for the Quality of Medicines & HealthCare, found that Zhejiang Huahai did not comply with good manufacturing practices in making valsartan at its Chuannan manufacturing facility site in Linhai, China.
The EMA issued a statement of non-compliance for Zhejiang Huahai, and the Linhai site is no longer authorized to produce valsartan for EU medicines.
In August, the FDA sent Zhejiang Huahai Pharmaceutical a Form 483 following a summer inspection of its Chuannan facility.
While a redacted version of the form did not disclose whether the observed issues directly concerned valsartan, the form reaffirmed concerns about Zhejiang Huahai's manufacturing practices.
The issues highlighted in the Form 483 include inadequacies in the change control system, issues with validating some control test procedures and having quality systems that ensure APIs meet their specifications.
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