EMA non-compliance report on Brazilian manufacturer of sterile medicinal products
During an inspection, the french authorities found major deficiencies at the site of a Brazilian manufacturer of sterile medicinal products. Learn more details about the EMA's non-compliance report.
Non-Compliance Report for manufacturing of three Products at Biocon, India
The European Medicines Agency (EMA) and the French Agence nationale de sécurité du médicament et des produits des santé (ANSM) published a Non-Compliance Report after a Pre-Approval Inspection for three biosimilar products of Biocon Limited in Bangalore, India.
EMA non-compliance report on Indian manufacturer of sterile medicinal products
During a pre-approval inspection, the French supervisory agency found major deviations by an Indian manufacturer of sterile medicinal products. Find out more details about the EMA's non-compliance report here.
Burkholderia cepacia - FDA Advice on Contamination Risk
Recent recalls determined FDA advice to drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products.
Guidance for Industry: Transmission Risk of West Nile Virus from Living Donors of Cells and Tissues
The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) updated the Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".
Revisions of EP Chapter 5.1.8, 2.6.36, 2.6.38 and Monograph 3053
In April, the Pharmeuropa issue 29.2 was completed including the revision of chapter 5.1.8. "Microbiological Quality of Herbal Medicinal Products for Oral Use and Extracts Used in their Preparation".
Recent FDA Warning Letter: Issues with Monitoring of microbiological Environments
Because of various severe GMP violations, the FDA issued a warning letter to an American manufacturer of wound disinfactants. The authority especially criticised deviations in monitoring of microbiological environments. Read the more about the Warning Letter to Aplicare from December 2016.
Warning Letter for Brazilian Manufacturer of Antibiotics
In the course of an FDA inspection at a Brazilian manufacturer of antibiotics, the inspector observed a few serious GMP violations which led ultimately to a Warning Letter. Read more about the FDA Warning Letter issued to the company Antibioticos Do Brasil Ltda.
Insufficient environmental monitoring as well as inexistent smoke studies on a RABS (Restricted Access Barrier System) resulted in a Warning Letter for the Japanese manufacturer Sato Pharmaceutical Co. Ltd.
Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Part 2
As a consequence of significant GMP violations, the US-American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Learn more on the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd.
Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Part 1
Following serious GMP violations, the American FDA issued an unusually severe Warning Letter to a Hungarian company in October 2016. Severe also because the authority put the company on the list of import bans until the defects have been fixed. Learn more about the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private.
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus
The FDA published the final version of the Guidance for Industry" Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".
FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections
An FDA investigation associated with a multistate outbreak has identified the bacteria Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured. More details at the FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections.
Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 3
Once again, the American FDA has addressed a Warning Letter to an Indian Manufacturer of sterile medicinal products. Major and serious violations of GMP principles were identified at the Indian Manufacturer Emcure Pharmaceuticals Limited. Part 3 of this news will deal with the issue of insufficient documentation. You will find more information on the most important deficiencies in this Warning Letter here.