Warning Letters Special Report: A Focus On Sterility Risks From Water Systems, Open Cleanrooms
A B. cepacia contamination recurrence led the US FDA to double down on sterility assurance of water systems in 2022, a trend likely to continue, Part 7 of our series finds. Open cleanroom contamination continued to drive warning letters as Annex 1 policy revision adds incentives to separate workers from injectable drug products with access barriers or isolators.
You may also be interested in...
Facility owners should ensure they are ready when asking for the meeting on deficiency remediation because only two requests are allowed per warning letter.
The heads of Sun, Cipla, Zydus, Lupin and Dr. Reddy's discuss moves to drive innovation including equity stakes for academia in research ventures as India approves an apex body to promote, fund and mentor research. Ways to progress ESG goals were also discussed at the IPA summit.
In the first part of our in-depth series, the Pink Sheet outlines how 2022 warning letters reflected agency’s efforts to overcome COVID-19 travel restrictions. As pandemic abates, a new, less inspection-intensive normal could emerge.