Be aware: FDA has issued a number of 483s related to the water used in nonsterile compounding....
We asked, FDA listened
Some of you may recall during this year's Compounders on Capitol Hill, Scott Brunner interviewed FDA's Gail Bormel. Among other things, they discussed how compounding pharmacies can avoid repeat 483 findings, and how FDA could educate compounders about them and how to avoid them.
Gail told Scott she liked this idea and clearly, she took it to task: On December 14, FDA is hosting a webinar, What to Expect after an Inspection: 483s, Responses and Beyond. We hope you can attend.