OR WAIT null SECS
April 16, 2019
The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.
March 15, 2019
FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.
March 13, 2019
FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.
March 12, 2019
A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.
March 08, 2019
The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.
March 07, 2019
Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.
February 21, 2019
The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.
February 15, 2019
The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.
February 14, 2019
Big data technology company, Aigenpulse, has been granted with International Organization for Standardization (ISO) 9001:2015 and ISO 27001:2013 certification.
January 03, 2019
FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.