CPG Sec. 100.100 Responsibility for Reporting Possible or Potential Violations of Laws Administered by FDA, Regulations Issued by FDA, Other Possible or Potential Hazards to the Public Health
It is the responsibility of all FDA employees, whatever their grade or job designation, to promptly notify their supervisors for appropriate referral as soon as they become aware of any circumstances that may be a violation of any of the laws or regulations we enforce or administer, or pose a potential hazard to the public health. When necessary, each director and each equivalent official in the Office of the Commissioner shall be responsible for taking any necessary action within their own authority, and for notification to their appropriate offices. If any questions exist after such referral, the matter should be promptly addressed to the Associate Commissioner for Regulatory Affairs, who will then be responsible for determining necessary action within the agency. The Associate Commissioner for Regulatory Affairs will also be responsible for communicating with other Federal agencies and governments of other nations.
In any instances in which there is joint responsibility and authority, or any ambiguity of responsibility or authority between FDA and any other agency, FDA shall assume an obligation to be certain that everyone concerned, including those in other agencies, are aware of pertinent information in the possession of this agency.*
*Material between asterisks is new or revised.*
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.