BASIC GMP, GMP Enforcement, Quality / CMC Guidance, and More…
In the past week, we added the following 20 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.
The FDA posted 13 warning letters this week. A collection were from the Center for Tobacco Products. There was 1 warning letter issued to a PET firm, 1 to a device firm, and 1 to a compounding pharmacy. We cover all 3 in this post.
A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, I ask the following questions.
From microbial contamination to a pharmacist reporting blue specks on tablets where there should be none, here are last week's recalls.
In the past week, we added the following 31 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.
FDA posted 6 warning letters on the website this week. Among the group was 1 letter issued to a compounding pharmacy and 1 issued to a finished drug facility. We address both in this post.