US FDA Consultants

Manufacturers come to our FDA consultants for different reasons. Some are entering the US market for the first time. Others are two weeks out from an FDA inspection. A few have already received a warning letter. The starting point changes — the goal is always the same.

 

GMP Implementation & Certification : Getting your quality system right is the foundation of everything else. We work with manufacturers on MDSAP, 21 CFR 820, 21 CFR 111, and 21 CFR 211 — setting up systems that hold up during an actual FDA audit, not just on paper.

 

FDA Pre-Inspection & Mock Inspections : An FDA investigator walking through your facility will find things. The question is whether you find them first. Our mock inspections put your site through the same scrutiny — giving you time to fix issues before they become official observations.

 

Product Labeling — GAP Assessment & Guidance : FDA labeling requirements are specific. A gap assessment tells you exactly where your current labels fall short — product by product, claim by claim — before your product enters the US market.

 

FDA Form 483 Responses : Fifteen working days. That’s how long you have to respond to a 483. A weak response increases the chance of a warning letter. We write responses that are technically accurate, well-evidenced, and built around a CAPA plan the FDA will find credible.

 

Warning Letter Remediation : A warning letter signals the FDA has lost confidence in your operation. Rebuilding that trust takes more than a written response. We help manufacturers put together a remediation plan that addresses root causes — and follow through until FDA closes the matter.

 

FDA DMF Preparation & Submission: Drug Master Files require precise documentation and careful formatting. We handle preparation, submission, and any follow-up correspondence with FDA across all DMF types.

 

FDA 510(k) Preparation & Submission : A cleared 510(k) starts with the right predicate device. From there, the substantial equivalence argument, performance data, and submission package all have to hold together. We manage that process start to finish — and know where most submissions run into trouble.

 

Product Classification : Before any regulatory pathway can be planned, the product has to be correctly classified. Device, drug, biologic, combination product — each carries different requirements. We work through the classification with you and lay out what it means for your path to market.

The Notice of Inspectional Observations, officially known as FDA Form 483, is typically issued by an FDA officer in response to a violation of Good Manufacturing Practices (GMP) in the food, drug, medical device, or cosmetic manufacturing or supply chain after the scheduled onsite audit.

 

Recipients of a US FDA 483 warning letter, whether by post or email, are required to respond to the FDA within 15 working days. Manufacturers must understand that a non-technical or poorly constructed response may result in a permanent warning and increased chances of further enforcement action by the FDA, including repeated inspections at short notice.

 

In any case, a Corrective and Preventive Action (CAPA) plan with a detailed schedule and timeline must be submitted. This is where the expertise of US FDA Consultants becomes invaluable. They can help ensure that the response is comprehensive, technically sound, and meets the FDA’s expectations.

 

This can greatly reduce the risk of further enforcement actions and help manufacturers maintain compliance with FDA regulations. I3CGlobal team of experts help manufacturers respond to FDA.