FDA cGMP Inspections in US Getting More Intense
Latest FDA and cGMP Compliance News US FDA cGMP audits continue to be getting tougher, partially because the priorities of FDA and their definition of cGMPs continue to change. In past years, we have seen that QA managers in the pharmaceutical industry generally knew what they could inspect from an FDA audit. The inspections would […]
Read More »Category : Compliance Tips &News
GSK Bribery in China Coordinated at High Level?
Source: Pharmalot Latest FDA and cGMP Compliance News The version of events that we are seeing from GlaxoSmithKline on the very embarrassing bribery mess in China is getting a lot of questions. The most recent confusion is coming from a report from the news agency Xinhua, where Huang Hong, general manager of GSK operations in […]
Read More »Category : News
Two More Indian API Companies Earn FDA Warning Letters
Latest FDA and cGMP Compliance News Two Indian drug companies – Promed Exports and Posh Chemicals – are the latest firms in that country to receive serious FDA warning letters. Promed is a drug maker, and Posh is a manufacturer of APIs. Both companies were sent warning letters citing them for cGMP regulation violations and […]
Read More »Category : News
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, […]
Read More »Category : News
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 […]
Read More »Category : News
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 […]
Read More »Category : News
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 […]
Read More »Category : Compliance Tips &News
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 […]
Read More »Category : News
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, […]
Read More »Category : News
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 […]
Read More »Category : News
