Archive for January 2021
483 Roundup: Inspections Reveal Lapses at Five Device Facilities
FDA investigators observed problems with equipment calibration, validation studies and design verifications among other failings during inspections of five device manufacturing facilities. Source: The GMP Letter
Read MoreEU Launches First of Six Eudamed Modules
The European Commission (EC) launched a new registration module in December for Eudamed, the EU database that will be used to monitor the safety and performance of devices under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Source: The GMP Letter
Read MoreHow Post-Brexit Changes Will Impact Devicemakers
The UK and the European Union wrapped up a landmark trade deal on Dec. 24 — just days before the UK completed its transition out of the EU. Although not specifically targeted at medical devices, the pact acknowledges existing arrangements for devices. Source: The GMP Letter
Read MoreFDA Continues to Target Unapproved COVID-19 Tests
The FDA issued 16 warning letters in 2020 related to COVID-19 diagnostic tests, most of them marketed directly to consumers, and the agency said it will continue targeting those this year. Source: The GMP Letter
Read MoreEU Clarifies Expectations for Remote Audits
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Source: The GMP Letter
Read MoreFDA Publishes Two Guidance Documents on Naming New Drugs
FDA has published two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors. Source: Drug GMP Report
Read More483 Roundup: FDA Raps Four Facilities for Quality Failures
FDA inspections revealed good manufacturing practice and other deficiencies at drug manufacturing facilities in New Jersey, Vermont and California, leading to Form 483 inspection observations for four firms. Source: Drug GMP Report
Read MoreFDA Limits Controlled Correspondence Options for Generic Drugmakers
A final guidance published Dec. 17 indicates the FDA will limit the kinds of questions generic drug sponsors may submit to the agency to get feedback during drug development. Source: Drug GMP Report
Read MoreFlorida Drugmaker Hit for Microbial Contamination
A Florida manufacturer of over-the-counter drug products had high microbial counts in water it used for manufacturing among other significant violations of current good manufacturing practice, according to an FDA warning letter to the firm. Source: Drug GMP Report
Read MoreCOVID-19 Vaccines Under Criminal Threat, Agencies Warn
Warnings of international crime targeting the yet-to-be-approved COVID-19 vaccines are getting louder, with the international police agency Interpol issuing an Orange Notice, which warns of an “imminent threat to public safety.” Source: Drug GMP Report
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