Pharmaceutical & Health Technology

 View Only

  • 1.  Complete Access to FDA 483s and EIRs

    Posted 03-31-2022 09:21

    Hi Everyone,

    We're looking for a subscription product which would provide complete access to FDA 483s and EIRs, including from the most current inspections, across regulated products (e.g., drugs, devices, biologics, vet meds, and tobacco).

    And we need it for more than drugs and biologics….. for firms, and 483s and EIRs from specific inspections.

    Thank you for any suggestions!

    Betty Edwards | Senior Manager, Business & Scientific Literature

    Digital and Enterprise Capabilities (DEC)

    Sage Therapeutics | 215 First Street, Cambridge, MA 02142

    617-475-7439 | betty.edwards@sagerx.com | www.sagerx.com



  • 2.  RE: Complete Access to FDA 483s and EIRs

    Posted 03-31-2022 09:34
    Hi Betty:

    I have used the following to search for 483s and EIRs.  Access all depends on if these organizations acquired them from FOIA, so one vendor may have it, but another doesn't.  If you use FDA's FOIA, be prepare to wait years (yes, years!) to get documents.



    ------------------------------
    Kimberly A. Flanagan-Bouchard, MLS, CIP™- II
    Associate Director
    Competitive Intelligence & Library Services (CI-LIB)

    Daiichi Sankyo, Inc.
    211 Mt. Airy Road
    Basking Ridge, NJ 07920 • USA
    Phone +1 908 992 7136
    Mobile +1 732 742 9275
    kflanagan-bo@dsi.com
    www.daiichisankyo.us

    ------------------------------

    Original Message


  • 3.  RE: Complete Access to FDA 483s and EIRs

    Posted 04-01-2022 06:50


    Thank you Kimberly - I really appreciate this information!

    Betty

    Original Message


  • 4.  RE: Complete Access to FDA 483s and EIRs

    Posted 03-31-2022 11:49
    Hi,
    Currently using Redica Systems to retrieve 483s , EIR reports 






    Original Message


  • 5.  RE: Complete Access to FDA 483s and EIRs

    Posted 04-01-2022 07:28


    Christine - thank you so much for your assistance - I will check out this link you recommended!

    Betty
    Original Message


  • 6.  RE: Complete Access to FDA 483s and EIRs

    Posted 03-31-2022 12:51
     Hi Betty. FOI Services can do one-off requests, but we do not have a subscription service. Redica Systems does have a subscription. Even if they don't have the EIR/483, they usually have some info about the inspection that might be helpful.

    483s are usually pretty fast & easy to get (a couple weeks to 3 or 4 months, depending on which FDA office is handling the request). EIRs, on the other hand, take much longer. The FDA can't send them until after the inspection has been completely closed out, so they recommend waiting 6 months to a year after the date of the inspection to request them (if you request an EIR before the inspection is closed out, you will just receive a No Records letter). Some offices will put EIR requests in the fast track and will fill them in about 3-4 months or less, but some, like Center for Devices, will route them to the complex queue, which has an 18-24 month wait time.

    Also, FDA deletes their inspection records after a certain amount of time (I believe it is 15 years for NAI and 30 years for VAI/OAI, though some centers follow this more stringently than others), so if you ever need something really old check with me, as we have a lot of EIRs and 483s from the 80's and 90's that FDA no longer has. 


    Rachel Johnson
    MLIS Candidate

    Senior Information Specialist 
    FOI Services
    301-975-9400
    rjohnson@foiservices.com



    Original Message


  • 7.  RE: Complete Access to FDA 483s and EIRs

    Posted 04-01-2022 07:31



    Rachel - Thank you for the detailed explanation (and the caveats as well)!  I appreciate it.

    Betty

     


    Original Message


  • 8.  RE: Complete Access to FDA 483s and EIRs

    Posted 04-01-2022 10:06
    Hey Betty!

    Have you looked into Govzilla from Redica Systems? 2 of my clients have it and appreciate its value Redica/Govzilla brings to the table. Also Redica partners with FOI Services too!

    Hope that helps!

    Stay safe & Cheers,

    Chrissy

    ------------------------------
    She/Her/Hers/Herself
    Christine (Chrissy) Geluk, M.S.L.I.S.
    Principal & Founder
    Librarian At Your Service LLC
    support@librarianatyourservice.com | Chrissy@librarianatyourservice.com | Twitter @cmgeluk | Instagram @cgeluk
    ------------------------------

    Original Message


  • 9.  RE: Complete Access to FDA 483s and EIRs

    Posted 04-04-2022 08:17

    Thanks for this information, Chrissy.  I am looking into it!

    Betty

    Original Message