Archive for April 2019
483 Roundup: Six Device Firms Cited for GMP, Other Failures
The FDA hit six facilities for various failures including inadequate validations, CAPAs, written procedures and supplier evaluations. Source: The GMP Letter
Read MoreTGA Ends Three Year Transition to ISO 13485:2016
Australia’s Therapeutic Goods Administration reached the end of its three-year transition period to the 2016 version of ISO 13485 and devicemakers using the updated standard to show Quality Management System (QMS) conformity are now expected to have their systems up-to-date. Source: The GMP Letter
Read MoreFDA Moves to Improve Mammography Quality Standards
The FDA issued a proposed rule aimed at modernizing mammography quality standards and better positioning the agency to act when violations are found. Source: The GMP Letter
Read MoreFDA Warns Two Breast Implant Makers Over Post-Approval Studies
Two breast implant manufacturers were served with warning letters after the FDA found they failed to comply with post-approval study requirements. Source: The GMP Letter
Read MoreFDA Proposes Total Product Lifecycle Approach to AI Devices
The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed rulemaking issued April 2. Source: The GMP Letter
Read MoreMHRA Issues Guidance for Air Shipping Medicines in No-Deal Brexit
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released guidance for EU drugmakers shipping medicines by air freight to the UK in the event of a no Brexit agreement. Source: Drug GMP Report
Read More483 Roundup: FDA Cites Five Drugmakers for GMPs, Other Issues
The FDA hammered five drug manufacturers — one Indian and four American — for varying issues at their drug making facilities, sending the companies Form 483s for their violations. Source: Drug GMP Report
Read MoreWarning Letter Roundup: Five Firms Warned for Serious Violations
Five American drugmakers were hit with warning letters after the FDA discovered an assortment of issues at their facilities, including contamination risks, missing procedures and issues with cleaning. Source: Drug GMP Report
Read MoreFDA Lays Out Final Rules for Pediatric Labeling
The FDA released a final guidance on pediatric labeling of prescription drugs that, among other recommendations, calls for black box warnings on medicines with inactive ingredients that might be dangerous to babies and children. Source: Drug GMP Report
Read MoreTGA Lists Pharmacovigilance Deficiencies in First Inspection Metrics Report
Some Australian drugmakers are still figuring out how to pass muster during the Therapeutic Goods Administration (TGA)’s new pharmacovigilance inspections introduced in 2017, according to the TGA’s first metrics report. Source: Drug GMP Report
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