News

A court in the UK has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified stability data to the MHRA in order to obtain a Marketing Authorization for a product. This was preceded by years of investigation by the authority.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Thailand. The violations include failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to release and distribution.

A non-compliance report was issued by the inspecting Maltese authority following an inspection at an Indian pharmaceutical manufacturer. The inspection was the follow-up inspection to an inspection already carried out in 2022, which was intended to monitor the implementation of the measures. According to the authority, the remaining deficiencies and risks of cross-contamination were problematic.

When reading an FDA Warning Letter, you might have recognised that under GDUFA programme, the facility may be eligible for a so-called Post-Warning Letter Meeting. But what is this?