Chinagate Scandal Now Implicating Alcon
Novartis is again getting caught up in a huge bribery scandal in China that has ensnared several drug makers. In July, a sales rep accused Alcon of giving bribes to some physicians in hospitals to increase sales of cancer medications. Now, we are seeing a whistle blower by the anonymous name of Zorro who is […]
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Oops, They’re In Trouble Again – Ranbaxy Labs Import Alert
Latest FDA and cGMP Compliance News In a massive setback for the embattled Ranbaxy Laboratories, FDA last week sent out an import alert on the products that are made at a plant in Mohali, India. This is one year after getting an F grade during an FDA cGMP inspection. This disclosure has sent the firm’s […]
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Pfizer Screw Up Leads to Nerve Gas Antidote Shortage
Latest FDA and cGMP Compliance News If you are wondering how using chemical gas in Syria has an effect on the US, here you go. A division of Pfizer is having trouble making enough pre filled syringes that have antidotes for sarin nerve gas. Some US public health experts are worried that the US will […]
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Prescription Fish Oil Pill Stink
Latest FDA and cGMP Compliance News Source: Pharmalot There has been a new twist in the ongoing prescription fish oil pill saga with Lovaza, which sells over $1 billion a year for GSK. A federal appeals court recently cleared the way for new generic versions of the drug. However, the news could prove to be […]
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Major R&D Changes Planned at Merck
The new top scientist at Merck is planning a lot of changes in the second biggest drugmaker in the US. Some of the planned changes include getting rid of dead end research plans and focusing its labs more on cancer drugs and biotechnology. The new research and development chief for Merck, Roger Perlmutter, talked about […]
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FDA Announces New Warnings on Opioid Painkillers
Source: Pharmalot Due to the concerns about the frequent abuse of many types of prescription painkillers, FDA now is going to require major label safety changes and several types of new post market study requirements for many types of long acting and extended release opioids. Their hope is to cut down on the incidents of […]
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Most Common FDA 483 Violations for Medical Devices
Recent FDA Compliance News According to recent FDA CDRH information, the most common 483 violations in the medical device industry are the following: Corrective and preventive action procedures (CAPA) – CFR 820.100(a) Complaint procedures -Â CFR 820.198(a) Corrective and preventive action documentation – 820.100(b) Process validation – 820.75(a) Written MDR procedures – 803.17 Below are […]
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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 […]
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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 […]
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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 […]
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