FDA Warning Letter to Drug Manufacturing Facility in Thailand
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.
APIs in Brazil: how to register and obtain the GMP certificate
In February 2024, the ECA offered the Live Online Training "How to register APIs in Brazil - Focus on CADIFA and obtaining a Brazilian GMP certificate". During the Q&A sessions, many interesting questions were posed to the speakers' team. A list of useful abbreviations and definitions in regard on the Brazilian registration system are collected and provided in the following.
Non-compliance Report (EudraGMDP): Cross-Contamination Risk at Indian pharmaceutical Company
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?
Even animals with legs can keep the regulatory authorities busy. In December, a US manufacturer received a Warning Letter, the first section of which deals with deficiencies in the area of pest control.
FDA Warning Letter: Data Integrity issues while manufacturing APIs
In February 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Sichuan Deebio Pharmaceutical Co. Ltd." after having inspected its site in September 2023. According to the Warning Letter the firm has a lack of microbiology laboratory Data Integrity.
Another FDA Warning Letter for Chinese Company based on Review of Records
The U.S. Food and Drug Administration (FDA) has issued another Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals, based on a review of records.
The House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing, which focused on the comparative frequency and quality of FDA inspections for foreign versus domestic drug manufacturers. Read more in our GMP News.
FDA Warning Letter: Observed particulates in repackaged drug components
In January 2024, the U.S. FDA issued a Warning Letter (WL) to the Mexican company "Glicerinas Industriales, S.A. de C.V." after having inspected its site in May 2023. According to U.S. FDA Warning Letter, the firm failed to do adequate investigations on observed contamination of particles in numerous packaged drugs.
FDA answers Questions on Remote Regulatory Assessments
The FDA has revised its Draft Guidance for Industry "Conducting Remote Regulatory Assessments - Questions and Answers", providing answers to frequently asked questions regarding what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.
FDA Warning Letter for Chinese Company based on Review of Records
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals. The firm failed to conduct proper analytical testing of incoming API lots and relied solely on supplier COAs without verifying the information. Additionally, there was a lack of documentation for the stability program.
EMA: Further Update of the Q&A Documents on "Centralised Procedures"
In December 2023, the Questions & Answers (Q&A) documents related to centralised procedures were revised again and published on the European Medicines Agency (EMA) website. The list of Q&As, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to any questions that may arise at different stages of the centralised marketing authorisation application.
FDA Warning Letter for not answering a Request for Inspection
We recently reported on a case in which the failure to respond led to a Warning Letter. The U.S. Food and Drug Administration (FDA) has now published another incident that also goes in this direction. The FDA had planned an inspection at a manufacturing facility in Thailand, but all efforts to contact the firm were unsuccessful.
Two FDA Warning Letters: Identity Testing of Incoming Components
The U.S. Food and Drug Administration (FDA) has published two new Warning Letters to companies registered as a manufacturer of over-the-counter (OTC) drug products in the United States. In both cases, the firms did not demonstrate that they adequately tested each shipment of each lot of the incoming components at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination.