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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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"Your firm's quality systems are inadequate". A sentence in a Warning Letter you would not like to read. Some companies now had to.

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The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.

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Quite a few authorities in the health care sector come for GMP inspections also to foreign countries. Here you can read what Russian inspectors will expect.

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The US FDA has recently published a Warning Letter describing the deficiencies observed during an inspection performed in September 2018 at a US pharmaceutical manufacturer. One serious deficiency concerns leaking product containers. Furthermore, defects in the stability programme, in the CAPA system and in data integrity have also been reported.

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The FDA has confirmed two other EU Member States to carry out GMP inspections at a level equivalent to that of the US. Only two states are still missing to implement the Mutual Recognition Agreement (MRA) between the FDA and the EU.

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In May, the FDA published a Warning Letter to a US American sterile manufacturer of ophthalmic drugs which highlights serious deficiencies, especially in sterile production and in the general understanding of GMP. Read more here.

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Due to fundamental GMP deficiencies, the FDA has issued a Warning letter to a US manufacturer of homeopathic drugs for human and veterinary use.

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