drug experience associated with the use of the drug in clinical studies that was fatal or life- threatening – 15 Day IND Safety Reports: Any adverse experience associated with the use of …

Dec 5, 2008 · If you are filling bottles with drug substance, then you need to consider the following when you conduct your investigation: 1. The process of printing the labels - In the …

Jan 1, 2022 · we have had an interesting discussion about the purpose of the deviation section and handling of the events noted during the method validation analysis The contents of the …

Oct 21, 2024 · After investigating, it turns out an employee was cleaning a production area at the time and sprayed a cleaning solution which affected the particle count reading. A re-sampling …

Dec 19, 2024 · Hi all It is very common that medical device companies are documenting and tracing design requirements and V&V in a matrix format for traceability, but to my impression is …

May 7, 2013 · US Food and Drug Administration (FDA) . FDA relabeler and repacker requirements for Medical devices ...

Nov 13, 2024 · I have objective evidence of an investigation of the action request we discussed during the on site audit that shows we did our due diligence and have retained documentation …

Dec 31, 2022 · DuPont Nutrition USA Inc. - 627211 - 12/02/2022 1. Your firm failed to perform adequate investigation of complaints. 2. You failed to thoroughly investigate OOS results in a …

Apr 22, 2013 · The second choice from the top at the DRLM Main Menu page allows you to see your facility information (which I understand is not changing), your owner/operator information …

May 15, 2013 · Fortune's investigation yields the first comprehensive picture of how one under-policed and far-flung generics company operated. It is not a tale of cutting corners or lax …