Tianjin Zhongan Pharmaceutical announced in 2010 that it had passed its first FDA inspection with flying colors, no 483 observations. Its most recent inspection didn't go as well. On Tuesday, the FDA posted a warning letter sent last week to the Chinese ingredient maker listing problems with keeping equipment clean and running down problems.
The letter is tied to an inspection done in September 2013 at its plant in Tianjin. Inspectors first noted that the company was not adequately cleaning equipment and that they had found "various levels of contamination and foreign objects inside" some unidentified units. The agency also chastised the company because employees documented that the equipment had been cleaned when it clearly had not, the warning letter says.
Further, the company had not documented changes it had made to processes. Inspectors knew because the company was using different equipment to manufacture some active pharmaceutical ingredients (APIs) than a filed flowchart indicated. And finally, the company didn't bother to investigate the source of particulate, including plastic that appeared to come from a pen that was found in at least one batch.
Read more: FDA finds fault with Chinese API maker - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-finds-fault-chinese-api-maker/2014-06-17#ixzz356xBUuWe
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The letter is tied to an inspection done in September 2013 at its plant in Tianjin. Inspectors first noted that the company was not adequately cleaning equipment and that they had found "various levels of contamination and foreign objects inside" some unidentified units. The agency also chastised the company because employees documented that the equipment had been cleaned when it clearly had not, the warning letter says.
Further, the company had not documented changes it had made to processes. Inspectors knew because the company was using different equipment to manufacture some active pharmaceutical ingredients (APIs) than a filed flowchart indicated. And finally, the company didn't bother to investigate the source of particulate, including plastic that appeared to come from a pen that was found in at least one batch.
Read more: FDA finds fault with Chinese API maker - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-finds-fault-chinese-api-maker/2014-06-17#ixzz356xBUuWe
Subscribe at FiercePharma Manufacturing
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