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November 14, 2018
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
November 12, 2018
The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
October 31, 2018
Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.
October 09, 2018
Audits by independent experts promise to ease the burden that customer audits can have on suppliers, while ensuring drug manufacturers that ingredients meet strict cGMP standards.
September 27, 2018
The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.
September 20, 2018
The agreement now includes 15 European Union (EU) member states.
September 17, 2018
FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.
September 12, 2018
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
September 01, 2018
Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.
July 19, 2018
The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.