FDA Update BD receives FDA warning letter over quality system violations Becton Dickinson (BD) has received a warning letter from the FDA regarding quality system violations at a facility that manufactures its Pyxis medication management system. The FDA identified several concerns, including: Failure to adequately investigate complaints: The FDA found over 92,000 complaints related to
Yes, the FDA has come out with the new FDA user fees for 2024. And as you can imagine the FDA is raising all fees from the annual registration to the 510(k)s. Annual Establishment Registration Fee for the coming year will be: $7,653 (talk about inflation – that is a 17% increase in the annual
GMP vs. ISO There has been a great deal of confusion concerning whether being in compliance with the medical device Good Manufacturing Practices (GMP) would successfully lead to obtaining ISO certification (with minimum changes and costs), or whether achieving ISO certification is going to be a long, expensive road. The ultimate success of your ISO
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