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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, DBA September 15, 2009. Outline. General Content Problems Labels SOPs Alternative Procedures and Exceptions Why We are Concerned. General Content Problems.

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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

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