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FDA Moves Toward Greater Transparency

The U.S. Food and Drug Administration (FDA) announced Thursday that it is disclosing more information about inspections and court actions, and now has a web portal on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. Now, FDA’s enforcement and compliance-related activities will be more accessible, downloadable, and searchable online.

According to FDA’s press release:

The information includes a summary of the most common Inspectional Observations of objectionable conditions or practices made during inspections and a searchable Inspections Database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification. By the end of 2011, FDA will also begin to disclose additional information about FDA evaluations of filers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall.

Access to this information about FDA’s enforcement and compliance activities will provide the following to the public and regulated industry:

— More information about company practices that may jeopardize public health, as well as about companies that have had satisfactory FDA inspections

— Information about recall and enforcement activities that will help consumers make decisions about products

— Information about inspection results, which can be expected to create a greater incentive to bring practices into compliance with the law

— Information about food products that are not subject to a particular recall, which can help reduce consumer confusion

The Transparency Initiative was first launched in June 2009. These most recent actions by FDA represent some of the first of the original proposals to be implemented.

© Food Safety News
  • re-FDA Moves Toward Greater Transparency
    i kindly would disagree with that assumption.
    Greetings FDA et al,
    does this include the ever ellussive mad cow feed ban warning letters ???
    the data base on failed inspections and ruminant feed is/was impossible to read.
    see the almost impossible here ;
    http://www.accessdata.fda.gov/BSEInspect/
    NOW, this new search is as complicated as the old one above ;
    http://www.accessdata.fda.gov/scripts/inspsearch/
    now compare to old feed ban warning letters. why can’t we just have the old warning letters back, where it is self explanatory $$$
    RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES — CLASS II
    ___________________________________
    PRODUCT
    Bulk cattle feed made with recalled Darling’s 85% Blood Meal, Flash Dried, Recall # V-024-2007
    CODE
    Cattle feed delivered between 01/12/2007 and 01/26/2007
    RECALLING FIRM/MANUFACTURER
    Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
    REASON
    Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
    VOLUME OF PRODUCT IN COMMERCE
    42,090 lbs.
    DISTRIBUTION
    WI
    ___________________________________
    PRODUCT
    Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007
    CODE
    The firm does not utilize a code – only shipping documentation with commodity and weights identified.
    RECALLING FIRM/MANUFACTURER
    Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
    REASON
    Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
    VOLUME OF PRODUCT IN COMMERCE
    9,997,976 lbs.
    DISTRIBUTION
    ID and NV
    END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
    ###
    http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm
    please tell me that the FDA is now posting these violations where the lay public can now find them again, and understand them ???
    kind regards,
    terry
    Thursday, May 26, 2011
    Travel History, Hunting, and Venison Consumption Related to Prion Disease Exposure, 2006-2007 FoodNet Population Survey
    Journal of the American Dietetic Association Volume 111, Issue 6 , Pages 858-863, June 2011.
    http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/travel-history-hunting-and-venison.html
    Friday, May 13,
    2011 EFSA Joint Scientific Opinion on any possible epidemiological or molecular association between TSEs in animals and humans
    http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/efsa-joint-scientific-opinion-on-any.html
    Tuesday, May 24, 2011 2:24 PM
    O.I.E. Terrestrial Animal Health Standards Commission and prion (TSE) disease reporting 2011
    http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/oie-terrestrial-animal-health-standards.html

  • Gabrielle Meunier

    Thanks Mike Taylor for moving in the right direction. I feel inspection records should be made available to the public. If the data is hard to read at this point, perhaps the FDA will work on that issue, but kudos for starting to put that data out there.
    Thanks.