Seres Therapeutics draws distinction between its quality practices and those of the fecal microbiota for transplantation (FMT) operations that triggered FDA alert.
Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.
APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.
Cadila Healthcare has confirmed receipt of a notice of concern (NOC) about its vaccine plant in Moraiya, India five months after the WHO inspectors criticized operations.
Out-of-place softgel capsules have led to the suspension of manufacturing at a site in France, and Catalent says the problem is almost certainly due to malicious actions.
The agency issued a warning letter and withdrew the GMP (Good Manufacturing Practice) certificate from Hyderabad, India-based Sri Krishna Pharmaceuticals for 10 GMP deviations found during an inspection at its Nacharam granulation plant in December.
Boehringer Ingelheim says it will pump a further €330m ($453m) into a German manufacturing facility critised by the US FDA in its rejection of the drug empagliflozin.
The European Medicines Agency (EMA) has published for the first time details of manufacturers who have violated GMP as part of its transparency initiative.
A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.
