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Again the US-American FDA has issued a Warning Letter which primarily describes defects in the water system as well as deficiencies in the handling of CAPA & OOS and in the cleaning.

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In August, the US FDA issued a Warning Letter due to cross-contamination with penicillin in areas for non-beta-lactam production.

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The Mutual Recognition Agreement (MRA) between the EU and the US is now in force as planned. But does this really mean the end of all FDA Inspections in the EU?

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A company in China has created GMP documents only for the purpose of inspection. With serious consequences.

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Indian sterile manufacturer Emcure Pharmaceuticals has once more received a warning letter from the FDA with concerns to the root cause analysis of deviations in sterility testing.

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The MRA with the USA is now in force as planned. But there is a lot to be considered in order to stop import testing.

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In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.

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Over and over again, FDA inspectors discover violations of long-established GMP requirements. Read more about which trends in the areas of quality control and production can be identified from the analysis of the Warning Letters issued in the last 21 months.

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An Indian manufacturer of solid dosage forms recently received a Warning Letter from the US FDA after the authority had revealed serious deficiencies in the tablet production.

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In a previous news it was pointed out that one EU Member State (Slovakia) was still missing for the complete implementation of the MRA agreement between the EU and the USA. The goal was for all EU Member States to be recognised by 15 July 2019. Now, this goal has been achieved.

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