FDA Finds Quality Void at California Compounder May 19, 2017 In a March 2017 visit to a compounding facility in Chatsworth, Calif., the FDA found there was no one in charge of quality. Read More
Italian Medicines Agency Cites Indian API Facility Over GMP Non-Compliance May 16, 2017 The inspection focused on one API, ambroxol hydrochloride. Read More
FDA Hits Allegiant Health for Lapses in Controls and Storage May 11, 2017 The investigators found the facility had inadequate controls for tablets. Read More
Italian Medicines Agency Cites Indian API Facility Over GMP Non-Compliance May 10, 2017 The Italian Medicines Agency cited Indian API manufacturer Kores for data integrity and systems security issues. Read More
CHMP: EMA Should Clarify GMP Communications for Non-EU Drugs May 10, 2017 The European Medicines Agency plans to clarify its role regarding drugs manufactured in the EU solely for the export market. Read More
MHRA Finds Increasing Trend of Sterility Deficiencies May 10, 2017 The U.K.’s Medicines and Healthcare products Regulatory Agency is finding more sterility assurance violations during facility inspections. Read More
FDA Cites API Manufacturer Over Inadequate Records and Testing May 8, 2017 The FDA hit API manufacturer Intas Pharmaceuticals over inadequate test records, water quality and other violations. Read More
FDA Warns American Specialty Pharmacy for Adulteration May 8, 2017 Inadequate responses to the agency’s observations prompted the warning letter. Read More
Petition Calls for Sentinel Query on Off-Label Use of Ulcer Drug May 5, 2017 The foundation has urged the agency to assess the risks posed by the drug. Read More
FDA Hits Allegiant Health for Lapses in Controls and Storage May 4, 2017 The FDA faulted drugmaker Allegiant Health for neglecting multiple controls in procedures at its New York facility. Read More
EMA Should Clarify Role in Collaboration on Non-EU Drugs, Officials Say May 4, 2017 EMA officials met with delegates to discuss the issue in a recent workshop in Malta. Read More
Divi’s, Teva Draw Warnings Over GMP Problems May 3, 2017 The FDA also says Divi’s limited the agency’s inspection. Read More