March, 2009


29
Mar 09

Natural Products Insider: FDA’s GMP Supplement Inspections

FDA’s GMP Supplement Inspections (Navigating a Brave New World): FDA is implementing GMP inspections of dietary supplement firms … are you ready?

Until the recent implementation of FDA’s inspection program under the new dietary supplement GMP (good manufacturing practice) regulation, perhaps the greatest change in agency inspectional procedures in the previous decade was the adoption of the principle that if your facility was operating, it was subject to inspection—even if the “management” was not on premises….

As the dietary supplement GMPs have begun rolling into effect, FDA has commenced implementation of its GMP inspection program. These inspections represent far more than a change in agency procedure; they are a sea change in the manner in which supplement manufacturers interact with investigators.

So, basically, manufacturers of supplements are now subject to inspection at the same level of scrutiny as drug and biologic manufacturers. Read the whole article for a brief description of what such an inspection entails.

(via @ChangeNetwork)


19
Mar 09

Twin Cities Biz Journal: FDA nearly doubles local staff, ready for regulation changes

FDA nearly doubles local staff, ready for regulation changes

The U.S. Food and Drug Administration has nearly doubled the number of inspectors in its Minneapolis office over the past year, marking a rebuilding of its local presence.

The FDA’s Minneapolis District Office now employs about 61 inspectors, up from around 34 last year. The hirings will help the agency recover from a recent wave of retirements, but also could mean some additional hassles for Twin Cities companies it regulates, as new, less-experienced inspectors are trained in.