[1]While the FDA generally determines violations through its own inspections, they can also issue one based on evidence from state personnel.
A step in this process, depending on the nature of the violation, is to issue a warning letter, which also establishes prior notice.
[3] The agency has a computer application called the Compliance Management System (CMS, or MARC-CMS) that district offices use to electronically submit warning letter recommendations to FDA Centers.
All district office must use the CMS to submit the warning letter recommendation, the Form FDA 483 that supports the alleged violations, the Establishment Inspection Report (EIR), and any written response from the firm.
[3] The warning letter includes the inspection dates and a description of the violating condition, practice, or product in brief but sufficient detail to provide the respondent the opportunity to correct the matter.
[3] The warning letter acknowledges corrections promised during the inspection, or that the organization provides to the district in a written response.
[3] The Warning Letter requests corrections and a written response within a specific period after receipt of the letter—usually fifteen working days.
If current good manufacturing practice (cGMP) violations are cited, it adds a statement regarding the potential impact on requests for approval of export certificates and drug applications.
[3] Device Warning Letters (except those issued to IRBs, clinical investigators, sponsors, and monitors involved in clinical trials) include the notice, "Federal agencies are advised of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
"Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.
[3] District offices do not recommend a Warning Letter as a follow-up to a preapproval inspection (PAI) for pending drug or device applications (ANDAs, NDAs, BLAs) if the firm markets no other FDA-regulated products.
[4] Additional enforcement actions (sequential or concurrent) available to the FDA to achieve correction are product recall, seizure, injunction, administrative detention, civil money penalties or prosecution.
[3] The FDA and the Federal Trade Commission issued their first joint Warning Letter on October 15, 2009, to a web site that was marketing fraudulent supplements.
These letters warn that they may be engaged in illegal activities, and informs them of the laws that govern prescription drug sales.