FDA – 70% of Dietary Supplement Companies Violate cGMPs
Latest FDA and cGMP Compliance News According to a top FDAer, approximately 70% of the supplement companies in the US did not follow all of FDA’s cGMP regulations for dietary supplements in the last five years. Recalls and FDA 483 reports have indicated that consumers are being put more at risk with dirty manufacturing equipment, […]
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Lonza Cutting Jobs at Massachusetts Plant by End of 2013
Latest FDA and cGMP Compliance News Lonza, a Swiss contract manufacturer, is going to begin to shut down operations at a troubled biologics facility that is located in Hopkinton MA. This will eventually lead to the loss of about 250 jobs. Originally, there was no time frame for the move, but now the company […]
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Fresenius Slammed With Warning Letter for Complaint Handling
Latest FDA and cGMP Compliance News FDA has issued another warning letter to the German health care company Fresenius, telling it to improve various cGMP procedures at its plants. This time the plant in the crosshairs is a blood bag making facility based in Puerto Rico. The warning letter from FDA hit the company for […]
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Tips to Qualify Your Pharmaceutical Ingredient Suppliers
Latest FDA and cGMP Compliance News As most of us know, the globalization of drug manufacturing and the move to the use of many overseas suppliers has greatly increased the complexity and vulnerability of the drug supply chain. That is why supplier and vendor cGMP compliance at all stages – purchasing, manufacturing and distribution […]
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China Bribery Scandal Widens: Ex Lilly Manager Says Docs Paid $5 Million
Latest FDA and cGMP Compliance News Eli Lilly is the newest pharmaceutical company to be drawn into the bribery scandal in China. The newest allegations are showing up at the 21st Century Business Herald, which is a newspaper in China that is reporting that an ex-senior manager at Eli Lilly says that $5 million was […]
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Is Troubled J&J Tylenol Plant Ready to Reopen?
Latest FDA and cGMP Compliance News Source: Pharmalot Johnson & Johnson is saying that its highly troubled manufacturing plant in Fort Washington, PA is going to be ready for an FDA cGMP audit next month. This is according to J&J CFO Dominic Caruso. That plant is a major manufacturing hub for many important OTC products, […]
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FDA Inspections Held Up By Visa Delays in China
Latest FDA and cGMP Compliance News A delay in getting visas for FDA auditors in China to work long term in that country is preventing FDA from increasing its cGMP audits there. It also wants to increase its regulatory oversight in China, and to collaborate more there on public health strategies. One staffer at […]
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Should a Prostate Drug Be Used to Stop Cancer?
Latest FDA and cGMP Compliance News Do you think that the Proscar drug and its generic versions be used to stop prostate cancer? This question is going to get a lot of attention, due to a new clinical study that shows that the drug (finasteride) could increase the risk of developing aggressive tumors. This issue […]
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Boehringer Ingelheim Closes WV Plant, Cutting 240 Jobs
Latest FDA and cGMP Compliance News The Boehringer Ingelheim Chemical Plant in Petersburg WV has been scheduled to close at the end of 2014. Last week, the company announced that it planned to close the plant, which will cut about 240 jobs. The plant produces active pharmaceutical ingredients, but the company says that some changes […]
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FDA Looks Closely at Opioid APIs
Latest FDA and cGMP Compliance News Source: Pharmalot FDA has given close attention to the cGMP quality of active pharmaceutical ingredients, or APIs. Now it is doing some heavy research on the specific APIs that are being used in opioids. FDA wants more work done at examining the APIs and also excipients, as well as […]
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