US FDA flagged GMP concerns at valsartan maker’s plants in two 483s

By Flora Southey contact

- Last updated on GMT

(Image: Getty/AlexLMX)
(Image: Getty/AlexLMX)

Related tags: Fda, Recall, China

The latest regulatory update in the valsartan recall saga comes from the US FDA, which has published Form 483s relating to inspections at Zhejiang Huahai plants in 2016 and 2017.

Zhejiang Huahai Pharmaceutical has attracted regulatory attention worldwide since detecting a ‘probable carcinogen​’ impurity in its production of valsartan, an active pharmaceutical ingredient (API) used in heart medicines, last month.

After initiating a recall of certain Zhejiang Huahai-made valsartan medicines, the US Food and Drug Administration (FDA) has published observations cited during two inspections at the API maker’s facilities in China. The inspections were conducted from November 14 to 16, 2016, and May 15 to 19, 2017.

In 2016, FDA inspectors visited the firm’s Xungiao finished dosage and API plant in eastern China. The resulting Form 483​ cites four observations, including a failure to follow written procedures designed to prevent contamination, and deficient cleaning and disinfecting systems.

In 2017, US inspectors visited the company’s Coastal Industrial Zone API facility in the same province and issued a Form 483​ with three observations. The heavily redacted report flags a lack of appropriate controls for Quality Control instruments as among the good manufacturing practice (GMP) deviations.

A second contamination?

The detection of N-nitrosodimethylamine (NDMA) in Zhejiang Huahai-made valsartan prompted the European Medicines Agency (EMA) to instigate a global recall​ of certain medicines in early July. The FDA has followed suit​ and the Chinese government has warned medical institutes against using the medicine​.

On Friday, the EMA announced that “much lower levels” ​of NDMA had been detected in valsartan medicines made by a second firm, Zhejiang Tianyu.

The EU regulator said it is working with international partners to review the impact of the NDMA detected in Zhejiang Tianyu-made valsartan and will “communicate as soon as additional information becomes available”.

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