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Repeatedly we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). There are three main documents.

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Everyone can now review 483s, 483 responses, Consent Decree Correspondence and other interesting documents in an Electronic Reading Room of the U.S. Food and Drug Administration (FDA).

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The integrity of data is currently in the focus of international authorities. In particular the US FDA issued serious violations in Warning Letters to the companies concerned. Read more about the current complaints in a Warning Letter issued to the API manufacturer VUAB Pharma.

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While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are in the spot light. On 15 June 2015 the National Agency for Medicines and Medical Devices of Romania entered a GMP Non-Compliance Report for Zhuhai United Laboratories into EudraGMDP. Read more about the GMP deviations observed at Zhuhai United.

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India continues to be the place were many manufacturing sites are found to be out of GMP compliance. This time POLYDRUG LABORATORIES was inspected and 17 GMP compliance violations were found. Read more about the GMP-Non Compliance Statement.

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Can an API manufacturer ask for an inspection to receive an EU GMP certificate? This is answered in the Question and Answers section of the EMA together with a question regarding the obligation to audit.

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Just recently a so called "inspection tracker" was launched by Health Canada. Now, the agency offers an additional database which contains 3,821 inspections (per March 2015) which have been performed since 2012 - many of them outside Canada, e.g. in Europe or Asia. Please read more about the GMP Inspection database.

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Data Integrity has become one of the most important GMP compliance issues in the past two years. This has enormous consequences for the concerned companies but also for companies and authorities in EU and US.  Again the US FDA has identified a company that violates regulations and put patients at risk. The company IPCA was already known for not meeting the GMP requirements. Read more about the GMP findings at IPCA and the consequences for companies and authorities dealing with Indian partners.

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The "FDA Voice" is a Blog which has been developed by the US Agency to post current initiatives, presentation and views. In a recent post published on March 24, 2014 Howard Sklamberg and Cynthia Schedar discuss ideas to improve the quality of inspections. Read more about the new FDA inspection appraoch.

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The MHRA has published a revised set of documents which are part of the risk based inspection system of the GMP Inspectorates in the UK. These documents are intended to help MHRA to get information prior to an inspection. Please read more about the MHRA risk ranking and the required Reports.

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