mdi Consultants, Inc
05
Aug
04
Aug
FDA Warning Letter on AI-Generated cGMP Records: What It Means
FDA Issues First Warning Letter Addressing AI-Generated Drug Specifications and Master Production Records FDA issues a Warning Letter addressing “the use of AI in creating the drug product specifications, procedures, and master production or control records” The FDA recently issued a warning letter to a US pharma company that had many FDA cGMP issues. This is the first time we have seen
The Mid-Year FDA Compliance Check: 5 Things to Verify Before Q3
Short answer: Before Q3 begins, medical device companies should verify five key compliance areas: FDA establishment registration, QMSR implementation, inspection readiness, U.S. Agent designation (for foreign manufacturers), and the status of any open FDA 483 corrective actions. Addressing these items now can help avoid compliance issues and last-minute challenges during the October registration renewal period.
10
Jun
What FDA Inspectors Are Actually Checking Under the New QMSR — MDI’s First-Hand Findings
What FDA Inspectors Are Actually Checking Under the New QMSR — MDI’s First-Hand Findings The single biggest focus area in every QMSR inspection that MDI has participated in is not your quality manual, SOPs/work instruction, documentation structure or your terminology — it is your organizations ability to demonstrate risk-based thinking embedded throughout your entire quality
07
May
FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
FDA Update PLEASE BE AWARE THAT THE FDA HAS LAUNCHED THE FOLLOWING PROGRAM. WHAT DOES IT MEAN TO YOU? FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources
06
Aug
The FDA Sends Two Warning Letters after Inspecting Chinese Syringe Manufacturers
FDA Update The Safety of Syringes Imported into the US Called into Question As: The FDA Sends Two Warning Letters after Inspecting Chinese Syringe Manufacturers The FDA named companies Jiangsu Shenli and Jiangsu Caina as targets of its investigation into the safety of plastic syringes made in China in March. The agency had not completed
12
Sep
FDA Inspections: How to Respond to a Request for an Affidavit
FDA Inspections: How to Respond to a Request for an Affidavit By Alan P. Schwartz, Senior Partner, mdi Consultants Dealing with the FDA during an inspection could cause real emotional stress to say the least. Should you respect the request of FDA investigator if you are not sure what the consequences would be at a
10
Feb
FDA update: Warning – The FDA Restarts Routine Domestic Surveillance Inspections
FDA Update February 10, 2022 Warning – FDA could be knocking on your door! The FDA Restarts Routine Domestic Surveillance Inspections With the decline of Covid-19 cases across the country, the FDA has decided to re-start their routine domestic surveillance inspections in the US. The FDA will also resume their foreign surveillance inspections provided that
13
Jul
FDA Update: COVID-19 Update – FDA prepares for resumption of domestic inspections with new risk assessment system
FDA Update – July 13, 2020 COVID-19 Update – FDA prepares for resumption of domestic inspections with new risk assessment system As a follow up to the update of July 10 on this item we have broken out some of the more critical areas on the FDA On-Sight Inspectional restart. The FDA is working towards
18
Dec
FDA Inspections in China with 5 day notice
BEWARE – FDA Inspections in China with 5 day notice mdi recently received an email from one of our clients in China that read: “We just received a “notice” from the USA FDA via the US Embassy in Beijing that there will be an inspection this coming Monday. Is this normal to be contacted from