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What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by Henry Macartney

FDA Warning Letter Form 483 ResponseSo you've received an FDA Form 483, but you were prepared. You completed a productive inspection close-out meeting and gained sufficient insight into the inspector's point of view to come up with an effective solution. Then, you submitted your formal response in time to avoid receiving a warning letter, having your facility shut down or being denied approval for that hot new product you've been toiling over. The only question is where you go from here.

Your FDA Form 483 response plan may only cover a few specific actions or a limited procedural change. Nonetheless, your ability to avoid similar inspection results in the future may hinge upon whether you can improve your quality management as a whole. 

What Prompts Inspectors to Use FDA Form 483s?

The general rule is that any source of concern observed during an official assessment is valid grounds for an FDA Form 483. Still, certain issues may be more likely than others to result in negative observations. 

The FDA Office of Regulatory Affairs keeps track of the number and types of Form 483s that are issued during each fiscal year. In 2013, it noted that the top three categories for drug-related Form 483s included improperly followed quality control procedures, failures to thoroughly review discrepancies and the absence of written procedures for process or production controls. Within device-related Form 483s produced during the same time frame, the top complaints were lack of properly established CAPA procedures, lack of complaint review procedures and lack of CAPA documentation.

Obviously, these figures shouldn't be interpreted to mean that FDA inspectors only hunt for certain things. It does make sense, however, that if specific issues are common throughout the industry; your next inspector may be more prone to keep an eye out for them. When your Form 483 response actions are limited in scope, you could just be setting yourself up for repeat failures.

Improving Your Response Capability

Life after an FDA Form 483 doesn't have to be difficult. If your response is effective, it may even become simpler than it was before the inspection. 

Instead of evaluating outstanding issues solely in terms of the systems they impact directly, you need to take a broad look at what they mean for your quality management system as a whole. Say you receive a 483 because you failed to maintain or produce a device history record for a pharmaceutical evaporator. While it's definitely a good idea to find the applicable records and ensure you keep better tabs on them from here on out, the fact that this wasn't an organizational priority in the first place may indicate that you're not emphasizing the right principles in your workplace.


Without top-down changes in the way you think and train your staff, it's only a matter of time before you get written up for the same fault in a different location. 

Can You Handle the Responsibility Alone?

While root cause analysis and similar methodologies are commonly held to be effective tools for implementing CAPAs and recovering after Form 483s, you may simply require a change of perspective. No methodology is effective in isolation, and if you can't step out of your shoes and evaluate your issues from an outsider's viewpoint, you'll overlook problems simply because you're so accustomed to them.

Regardless how you decide to bounce back from a deficiency, working with the consultants at GxP-CC is the easiest way to put your mistakes in context. GxP-CC also has a partnered law firm, who can quickly take care of the legal aspects of your 483. Contact them today to take advantage of their compliance experience.

Posted in CAPAs, Compliance Consultants, FDA & European Regulations, FDA Form 483, FDA Warning Letter, GxP CC, Quality Management Systems

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Henry Macartney

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