FDA Warning Letter to EU Company

Recommendation

7/8 May 2024

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All EU Member States are now part of the MRA (Mutual Recognition Agreement) between the EU and the FDA. The FDA was already recognised by the EU in 2017. The main objective was to mutually accept the respective GMP inspection systems and to reduce the number of foreign inspections.

But FDA is still coming to the EU to inspect. In the current EMA Questions & Answers document (EMA/395913/2019) it is said that it is (only) "expected that the FDA will not duplicate inspections conducted by a recognised authority". Both the EU and FDA will still have "the right to inspect in each other's territory at any time". So if a site in the EU has not been inspected yet by a competent authority or was inspected before the MRA came into force, FDA might still decide to inspect.

Not having an EU-GMP certificate might have been the reason why Ficosota Ltd. from Bulgaria was inspected by FDA in September 2019. According to the company's website, Ficosota's main business is soap and cleaning compound manufacturing. And the company is currently not listed in the EudraGMDP database. However it seems certain pharmaceutical products are manufactured at the site as written in a Warning Letter issued by FDA end of February 2020 as a consequence to the inspection: "This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals." 

Overall, Quality Oversight seems to be the biggest issue. It was observed that the quality unit "did not provide adequate oversight for the manufacture" of the OTC drug product. FDA criticized that the quality unit failed to ensure that:

• QU responsibilities to approve and reject API and drug products were defined;
• All testing was performed and reviewed by the QU prior to batch release;
• An ongoing program for monitoring process control was established to ensure stable manufacturing operations and consistent drug quality;
• Master production records and batch production records with detailed manufacturing steps and parameters were adequate and approved;
• An annual product review program was established;
• Adequate procedures for out-of-specification (OOS) were established;
• Any unexplained discrepancies or failures of a batch or any of its components to meet any of its specifications, were thoroughly investigated.

Furthermore, the company "failed to perform critical quality control tests of finished drug products prior to shipment to the U.S. market", "failed to adequately test incoming raw materials, including API and other components" and seems to have an inadequate stability program.

FDA placed the company on Import Alert 66-40 on January 10, 2020.