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Common Regulatory Problems with Submissions Rosia Nesbitt, BS, SBB(ASCP), CQA(ASQ) Consumer Safety Officer CBER, OBRR, D PowerPoint Presentation
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Common Regulatory Problems with Submissions Rosia Nesbitt, BS, SBB(ASCP), CQA(ASQ) Consumer Safety Officer CBER, OBRR, D

Common Regulatory Problems with Submissions Rosia Nesbitt, BS, SBB(ASCP), CQA(ASQ) Consumer Safety Officer CBER, OBRR, D

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Common Regulatory Problems with Submissions Rosia Nesbitt, BS, SBB(ASCP), CQA(ASQ) Consumer Safety Officer CBER, OBRR, D

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  1. Common Regulatory Problems with SubmissionsRosia Nesbitt, BS, SBB(ASCP), CQA(ASQ)Consumer Safety OfficerCBER, OBRR, DBASeptember 15, 2009

  2. Outline • General Content Problems • Labels • SOPs • Alternative Procedures and Exceptions • Why We are Concerned

  3. General Content Problems • Cover letter does not clearly indicate what is being requested • Cover letter does not include reference to all previously approved SOPs and/or Comparability Protocols for subsequent submissions

  4. General Content Problems (cont.) • License and/or registration numbers not included in the cover letter or on the Form FDA 356h • Staff contact information not included in the submission • telephone number • affected facility’s address

  5. General Content Problems (cont.) • “Doing business as” (dba) name used instead of legal name • Duplicate copy not always submitted with original • Form FDA 356h not included in submission

  6. General Content Problems (cont.) • Submitting the same documents by mail, e-mail and fax, resulting in receiving the exact same submission more than once • Submitting documents and or SOPs that are not required for the submission • Forms submitted with abbreviations with no explanation or legend

  7. Labels • Labels inconsistent with regulations or Uniform Labeling Guidelines • Example: incorrect font, donor classification not the same prominence as the proper name) • Form FDA 2567, Transmittal of Label Form, not included with label submissions • Form FDA 2567 not signed or incomplete

  8. SOPs • SOPs not reviewed for errors prior to submitting to FDA • Not submitting all applicable SOPs • SOPs contain discrepant information or information not consistent with the package insert, operator’s manual or CFR

  9. Alternative Procedures and Exceptions - 21 CFR 640.120 • Citing an incorrect CFR reference for requests for alternative procedures or exceptions • Not citing a CFR reference • Requests for alternative procedure or exception not clearly stated

  10. Why We are Concerned • Potential delay in completing review