Further Warning Letters after Remote Evaluations by FDA

As reported, the U.S. Food and Drug Administration (FDA) has introduced so-called "Remote Interactive Evaluations". According to the FDA, these remote evaluations do not fulfil the legal definition of an inspection and serve as a supplement to an inspection, but two Warning Letters have now been published again that were issued following a purely remote evaluation. According to the FDA Dashboard, no on-site inspections have been carried out to date. Last year, a Polish pharmaceutical company had already received a Warning Letter following a remote assessment.

One of these warning letters went to Xiamen Wally Bath Manufacture Co, Ltd, a manufacturer of over-the-counter medicines (OTC) from China.
The FDA found that the company had generally failed to adequately test raw materials and finished products. The FDA also found that the company did not have a valid scientific basis for determining stability data. As a result, the FDA placed the company on Import Alert 66-40 and may withhold approval of new applications or supplements listing the company as a drug manufacturer until the violations are corrected.
The FDA required the company to submit a comprehensive assessment and corrective and preventive action plan (CAPA) to ensure the adequacy of its stability programme. The FDA also asked the company to submit test results and procedures for all drugs imported into the United States. The company was given 15 working days to respond to the letter and remedy the violations.

Another Warning Letter was sent to a Turkish manufacturer of OTC medicines. Here the deficiencies were similar and medicines were not tested for stability properties, impurities and microbiological properties. The company also failed to provide evidence of testing of incoming batches of the active pharmaceutical ingredient (API).

Again, the FDA placed the company on import alert 66-40. The FDA also asked the company to submit a CAPA plan and a comprehensive assessment of its laboratory and stability programme and test results for all batches of its products shipped to the US.

The FDA also advised both companies to retain a qualified consultant to assist it in complying with the CGMP requirements.