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How Do I Respond to Violations?

 

Did you know there are two inspections going on simultaneously during your annual inspection?

Are you able to keep the State and FDA inspections separate?

Knowing the difference is especially helpful when responding to violations.  The FDA is only interested in clearing MQSA violations and has no need for any response to state violations.

 

State Responses

The inspector will be looking for the following State Inspection Requirements:

  • Shielding Design/Plan review

  • Letter of Acknowledgement

  • Report of Assembly (pink copy)

  • Post Installation Area Radiation Survey

  • Notice of Registration

  • Notice to Employees

  • State Regulations

  • Film Badge Records

  • Radiation Protection Program

  • Annual Review of Radiation Safety Program

  • Protective Aprons

  • Technique Chart

  • Self Referral Policy

  • Dissolution Policy

A deficiencies in any of these areas will generate state violations.

State Violation/Response Levels are as follows:

  • All items in compliance:                         No response necessary

  • Level IA Violation:                                15 days to respond

  • Level 1, II, III, IV, or V Violation(s):   30 days to respond

  • Responses are determined by the facility to reflect an acceptable attempt at correcting the violation.  Your inspector will not clear the violation until the response is deemed acceptable.  Do not respond to MQSA violations in your response to Radiation Protection for State violations.  State responses are to be mailed to the attention of your inspector to the following address:

    NC Radiation Protection  
    3825 Barrett Drive  Raleigh, NC  27609
    Phone:  (919)571-4141   Fax:  (919)571-4148

     

     

    MQSA Responses

    The most efficient way to familiarize yourself with citable deficiencies is to review the inspection questions in the FDA inspection software.  If any question is answered "No" the inspection software will issue a violation.  Inspection software questions can be found in the Policy Guidance Help System.  Click here for a copy in Word   

    Response Levels are as follows (lowest to most severe):

  • All items in compliance:                          No response necessary

  • Level III:                                                 No response necessary

  • Repeat Level III (same as Level II):    30 days to respond

  • Level II:                                                  30 days to respond

  • Repeat Level II (same as a level I):      15 days to respond

  • Level I:                                                    15 days to respond
  • Responses are determined by the facility to reflect an acceptable attempt at correcting the violation.  Your inspector will not clear the violation until the response is deemed acceptable.  Do not respond to State violations in your response to the FDA for MQSA violations.  You will need to send your response to the following address:

    Food and Drug Administration
    Abraham Maekele
    300 Fayetteville Street Mall, Suite 422
    Raleigh, NC 27601-1749 

    The FDA will not clear violations until your inspector clears your violations.  Therefore it is important that you send a copy of your response to:

    NC Radiation Protection Section
    (to the attention of your inspector)
    3825 Barrett Drive
    Raleigh, NC 27609-7221

     

     

    So remember, don't include State violations in your MQSA response  NOR  MQSA violations in your State response.

     

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