GMP News - Inspections/Audits

You can't actually believe what you read in the Form 483 that the FDA issued to the Emergent BioSolutions site in Baltimore - the site that suffered a mix-up in the manufacture of a Covid-19 vaccine.

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and  Drug and Biological Product  Inspections During COVID-19 Public  Health Emergency Questions and Answers Guidance for Industry" with some further clarifications.

From March 2020 to March 2021, the FDA carried out 821 mission-critical inspections, but only 49 of these were in the area of "Human Drugs". A recent report provides details and an outlook.

In April 2021, the U.S. FDA issued a Warning Letter to a Colombian API manufacturer due to significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs).

The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report dated into the EudraGMDP database due to serious GDP violations at a German wholesaler. The case involves trading of falsified medicinal products and storage of expired medicinal products in regular stock. Furthermore, there are doubts on the reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure.

Teleconferencing, livestreaming sessions and screen-sharing technologies will be used by the FDA in future remote evaluations- but these remote evaluations will not be considered inspections.

The U.S. Food and Drug Administration (FDA) recently published a Warning Letter to a Mexican firm whose facility is registered as a manufacturer of over-the-counter (OTC) drug products in the United States. The Warning Letter is not based on inspection findings from an onsite audit but on the review of documents that the company was required to send at the request of the FDA. The FDA found different serious deficiencies based on the submitted documents.