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AIP Procedures

1-1-7 Revoking The AIP As It Applies To A Firm's Application(S)

After the Center invokes the AIP, it may decide to revoke the AIP as it applies to the firm's applications and resume or begin review of those applications. Revoking the AIP is not the same as granting an exception to the AIP. The Center should not revoke the AIP for fewer than the total number of applications on which it invoked the AIP. For example, if the AIP was invoked for all of the firm's applications, the Center should revoke the AIP for no fewer than all those applications. The Center generally should consider all the criteria set out below before it revokes the AIP. However, items 1 and 2 should be met before the Center considers revoking the AIP.

  1. The applicant conducted a credible and adequate internal review designed to identify all instances of wrongful acts as a supplement to the Agency's independent investigation. The applicant's internal review involved a qualified outside consultant who was given freedom to conduct an independent and adequate audit.
  2. The applicant submitted and executed a CAP, which included:
    1. a commitment to assure safety, efficacy, and quality;
    2. a description of corporate ethics and compliance programs;
    3. procedures for effectively communicating to employees through written publications and training programs:
      1. the firm's SOP's, including its ethics and quality assurance programs, and
      2. the employees’ regulatory responsibilities to the Agency; and,
    4. the steps the applicant has taken to address current wrongful acts and to prevent future occurrences, such as:
      1. reasonable steps to ensure implementation of the CAP (audits and reporting systems);
      2. consistent enforcement of standards through appropriate disciplinary mechanisms;
      3. designating a specific, high-managerial agent or equivalent to be responsible for implementation of the CAP;
      4. identifying individuals who were or may have been involved in, or associated with, the wrongful acts, and removing them from positions of substantive authority on matters under the Agency's jurisdiction; and,
      5. retesting or recalling products with suspected data integrity problems as appropriate.
  3. The applicant withdrew any questionable application(s) and committed in writing:
    1. to not refile or reactivate any application not included in the validity assessment until the Agency is satisfied with the reliability of the data/information; or,
    2. when a validity assessment shows that an application contains unreliable data and the applicant wishes to replace the data, to submit a new application.
  4. The Center has received a memorandum from the Field Office/investigating unit signed by the appropriate manager, such as the District Office's Director, that confirms that:
    1. the applicant satisfactorily completed item 1;
    2. the applicant's CAP has been submitted and executed and, where applicable, any ongoing obligations have a timetable for completion; and,
    3. where applicable, questionable applications have been withdrawn.
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