As discussed in our previous post, “FDA 483: your company contains critical errors,” a company whose operations are not compliant with the regulations set out by the Federal Food, Drug, and Cosmetic Act and related acts (The Act) is likely to face serious consequences from the FDA. Although there are exceptions in the case of serious violations, a Warning Letter is generally issued by the FDA following an extensive review of site inspection results, usually within 30 days of the inspection close out. The purpose of a Warning Letter is to notify companies that they are operating in violation of The Act, and that they are expected to remedy all outstanding issues in order to become compliant. The significance of a Warning Letter versus a 483 is that a Warning Letter is an official statement by the FDA confirming that a company is operating out of compliance, whereas a 483 is an inspector’s (highly influential) opinion on the matter, but is not an official Agency statement. While neither a 483 or Warning Letter actually commits the FDA to taking any further action, most companies that receive Warning Letters will face some form of enforcement action should they fail to properly address all compliance issues identified in the Warning Letter. Enforcement actions can come in a variety of forms, including strict monitoring of operations, mandated suspension of operations, or even a criminal investigation.
The nature of Warning Letters varies greatly on a case by case basis. Prior to administering Warning Letters, the FDA does a thorough evaluation of the company in question, the specific issues raised, and actions that have been taken since the conclusion of the initial site visit. It is very important to evaluate the contents of a Warning Letter to identify what steps must be taken. For example, if a Corrective and Preventative Action (CAPA) plan has been created and submitted to the FDA, the Warning Letter identifies areas of the plan that are deemed insufficient. In some cases a Warning Letter is simply a statement that the submitted CAPA plan should be strictly followed in order to avoid enforcement action.
Most CAPA projects initiated by Warning Letters are difficult to plan and execute effectively because they must be managed by individuals with varied expertise. To begin with, while the FDA does provide explanations of what regulations are being violated and in what way, it takes knowledge of the applicable regulations and industry experience to fully understand the issues at hand. Once the regulatory issues are understood, technical system and hardware expertise must be leveraged to identify solutions. Next, the CAPA project plan must be drafted in a logical workflow that fits into an acceptable timeframe. Finally, the project must be executed in a precise, controlled manner that ensures an effective outcome. All of these tasks must be completed in rapid succession in order to demonstrate to the FDA willingness and ability to bring operations into compliance. At Globiox, we make it our mission to provide our clients with comprehensive assistance in such efforts through research and scoping for aspects of projects, and careful execution of all tasks to ensure that costly mistakes are avoided. Click Here to have one of our helpful team members contact you today.
Sources:
http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176870.htm
http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm254426.htm