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Pharmaceuticals / Regulatory Affairs

FDA Warns Georgia Drugmaker for Sampling, Cleaning Violations

May 13, 2019

Newton Laboratories drew a warning letter from the FDA for serious cleaning and manufacturing violations at its Conyers, Georgia facility.

In a March 26-30, 2018 inspection, the FDA investigator found the firm neglected to investigate excessive microbial counts for samples of water and finished products. Instead of finding the root causes of the failing results and the potential impact on quality and safety, the company had new samples tested by the contractor, the agency said.

“We note you routinely released drug products without the assurance that they meet their quality attributes,” the agency said.

The company also failed to show that its cleaning procedures rid contact surfaces of potential contaminants. Cleaning samples the firm took from equipment after production “routinely failed microbial testing,” the agency said, indicating a significant risk of product contamination with microbes, cleaning agents and drug residues.

The agency noted the firm’s homeopathic products included ingredients with potentially toxic effects, such as Nux vomica, which contains strychnine.

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