BiMo inspection FOIA log.This is a list of FOIA (Freedom Of Information Act) A U.S. government rule that states that public information shall be delivered within 10 days of request. requests for copies of 483s and EIRs for inspections of CROs, testing labs, sponsor/monitors, IRBs and clinical investigators A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under , which were filed with FDA FDAabbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. under the Freedom of Information Act (FOIA). This list does not imply that a 483 or EIR EIR n. popular acronym for environmental impact report, required by many states as part of the application to a county or city for approval of a land development or project. (See: environmental impact report) has been issued, only that a request for a copy has been made by a third party. These documents--if actually available--usually must be requested anew from our RECORD-RETRIEVE Service by referencing the FDA file # (e.g., F01023190), or you can submit on your own by referencing the FDA file number. (The weeks of Nov. 26 and Dec. 3, 2007, were used to compile this list.) To order any of these files, call our RECORD-RETRIEVE Service at (703) 779-8777, or e-mail at SERVICE@FDAINFO.COM (1) (Computer Output Microfilm) Creating microfilm or microfiche from the computer. A COM machine receives print-image output from the computer either online or via tape or disk and creates a film image of each page. Research site and request date FOIA File No. Ben Venue Labs, Bedford, OH, 5/7-6/15/07 2007-10744 Charles River Labs Preclinical Services, 2007-10841 Sparks, NV, 5/14-23/07 Difco Lab, Detroit, MI, Most Recent 2007-10534 Taub, M.D., Robert, New York, NY, 9/83-Present 2007-10706 |
|
||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion