FDA warns companies in India New Zealand cGMP violations

FDA warns companies in India and New Zealand for cGMP violations

7:02 AM, 17th September 2015
FDA warns companies in India and New Zealand for cGMP violations
The headquarters of the US Food and Drug Administration is shown in Silver Spring near Washington. © CNN photo.

MARYLAND, US: US Food and Drug Administration (FDA) issued a warning letter to a company in India and New Zealand citing violations of current good manufacturing practice (cGMP) regulations in September.

The FDA said Vadodara, India-based Pan Drugs Ltd had improper maintenance, repair, and cleaning of buildings used to manufacturer APIs.

The Auckland, New Zealand-based Jaychem Industries was noted for violations of cGMP regulations for finished pharmaceuticals observed during an FDA inspection conducted from 7 to 10 July, 2014. The company was also cited for manufacturing misbranded drugs, FDA said.

For Pan Drugs, FDA investigators observed holes in the walls and roof that gave pigeons access to areas where production equipment was used. They also observed gaps and holes in outside walls near piping and air ducts that could allow contaminates to enter the facility. FDA investigators “observed rust, dirt, lubrication leaks and exposed insulation material on and around open drug manufacturing equipment,” it said.

The company was also cited for failure to maintain complete analytical testing data, FDA said.

The company is required to obtain a third-party consultant to assess its operation and that the company contact the centre for drug evaluation and research’s drug shortages staff for help bringing the company into compliance to minimize the affect on the drug supply, the agency recommended.

For Jaychem, FDA stated that the company failed to ensure the quality of API from various suppliers; failed to establish adequate written control procedures; failed to test finished batches for identity and strength of APIs; and failed to provide data to demonstrate that chemical and physical properties of a product remain acceptable throughout the product’s lifecycle.

FDA also cited Jaychem for misbranding because some of the company’s sunscreen products had labels that claimed the products prevented sunburn, which would make them drugs as defined by the Food, Drug, and Cosmetic Act “because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man.”

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