FDA sends Warning Letter to EU Company after Remote Evaluation

Recommendation

15-17 May 2024
Berlin, Germany

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

As reported, the FDA has reduced its inspection activities due to the pandemic. Almost no international on-site inspections were carried out. However, the FDA has carried out so-called "Remote Interactive Evaluations". According to the FDA, these remote evaluations do not correspond to the legal definition of an inspection and serve more or less as a supplement to an inspection. But now a Warning Letter has been published that went to a company in Poland. And this happened after a pure remote inspection. According to the FDA Dashboard, no on-site inspection has never been carried out there.

The company manufactures over-the-counter drug products (OTC) and distributes a homeopathic cream in the USA. The FDA reviewed documents submitted in response to a June 2021 agency request as part of the remote assessment described in the Warning Letter.

The Warning Letter of March 2022 now summarises "significant" cGMP violations. The FDA criticises that the cream is distributed in the USA without having submitted sufficient data and documents for process validation. In addition, the documents submitted do not prove that the drug has the concentration stated on the label. There is a dilution discrepancy here of approximately 4C or 100,000,000 times the active ingredient concentration that the homeopathic medicine is supposed to have according to the label. Furthermore, there is a discrepancy between the temperature of the components recorded in the batch manufacturing record and the temperature range stated in the manufacturing instructions.
The FDA also lacks evidence that at least one test is performed to verify the identity of each component of a drug product.

The batch records submitted for review lacked "adequate production details", e.g. the identity of the equipment used, the duration of the process steps including the total duration of batch production and the persons who performed the process steps. A review of the Certificates of Analysis (COAs) submitted also revealed that appropriate specifications for the microbiological testing were not established.

The FDA now recommends that a consultant qualified under 21 CFR 211.34 be hired to assist the company in complying with cGMP requirements.

Even worse than the Warning Letter is the imposed "Import Alert 66-40". Until all violations have been fully corrected and the FDA has confirmed that the cGMP regulations are now being complied with, the FDA can deny new approvals or supplements.