GMP News - Inspections/Audits

15.10.14

FDA's New Inspection Data Dashboard

The US FDA has recently introduced a new service on their webpage. A new "inspection dashboard" provides information and analysis about the inspections which have been performed by the FDA in the previous years. Read more in our GMP News.

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01.10.14

EU GMP Inspectors find 26 GMP Deficiencies at Chinese API Manufacturer Hebei Dongfeng Pharmaceuticals

EU GMP Inspectors from the competent authority in Romania identified several GMP deviations during a GMP inspection at a Chinese API manufacturer. As a consequence, a GMP Non-Compliance Report has been issued. Read more here about the GMP Non-Compliance Report.

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24.09.14

New GMP Non-Compliance Reports available in EudraGMDP

Last month, new GMP Non-Compliance reports were issued for three pharmaceutical companies. The facilities concerned are located in India, Taiwan and Bulgaria. Read more about these new GMP Non-Compliance Reports.

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27.08.14

Chinese Company Refuses GMP Inspection and Gets an Import Alert from the FDA

The US FDA has placed the Chinese company Beijing Shunxin Meihua Bio-technical Co on an import alert. Read more here about the FDA Import Alert.

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20.08.14

Indian Sterile Manufacturer receives FDA Warning Letter and changes company name from Marck Biosience to Amanta Healthcare

Marck Biosciences Limited is a producer of sterile products which has been producing sterile products for the US market. The FDA Warning Letter dated July 8, 2014 contains shocking details about the GMP situation at this facility. Read more here about the FDA Warning Letter to Marck Biosciences and about the name change to Amanta Healthcare.

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13.08.14

Serious GMP Violations found at Chinese API Manufacturer - Basic GMP principles not followed

On 7 July 2014 the US FDA has issued a Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co., Ltd. located in Taizhou, Zhejiang Province in China. The company is a producer of APIs and failed to establish basic GMP principles. Please read more about the FDA Warning Letter.

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13.08.14

FDA 483s available in the World Wide Web

Besides Warning Letters, the U.S. Food and Drug Administration is also publishing other inspection documents. Read here where you can find them.

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16.07.14

Italian API Manufacturer Receives FDA Warning Letter for Data Integrity Issues

On July 7th the US FDA issued a Warning Letter to Trifarma S.p.A. for violating Good Manufacturing Standards at their facility in Rozzano, Italy. The company produces APIs and had been inspected early this year. Read more about this Warning Letter here

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02.07.14

New GMP Non-Compliance Reports in EMA Database

There are some new entries about GMP and GDP non-compliances in EudraGMDP, the European Inspection Database. Please read this news to find out more about the GMP and GDP Non-Compliance Reports.

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25.06.14

FDA issues Warning Letter for API Facility

The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility. Read more about the FDA Warning Letter.

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04.06.14

India under Pressure: GMP Conformity Not Guaranteed in many APIs Facilities

The pressure on India is getting bigger because of GMP deficiencies found during inspections. An article of the news agency Reuters summarised impressive information on the topic. Read more here about the Reuters article.

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14.05.14

Next FDA Import Alert for Indian Manufacturer due to GMP problems -also EU Inspectors find major GMP deviations

GMP Compliance problems found at more and more manufacturers in India are a major concern of EU and FDA regulators. Again the FDA has issued an Import Alert for an Indian Manufacturer. Please read more.

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23.04.14

Another FDA Import Alert for an Indian Manufacturer due to GMP problems

The FDA has issued an Import Alert due to serious GMP deviations for an Indian manufacturer. Read more about the FDA Import Alert.

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23.04.14

FDA wants to increase Number of foreign Inspections

According to the current Budget Request, FDA would like to perform approx. 20 percent more foreign GMP inspections. Read more.

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16.04.14

GMP Non Compliance Reports - Update in EMA Database

The EMA Database EudraGMDP is a major achievement for GMP and GDP compliance information.  Since parts of the data are now publicly accessible, it makes it easier to get important information relevant for supplier qualification. In our GMP News we list the 2014 updates for GMP-Non-Compliance.

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