How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making.

Response to the FDA Form 483

The FDA generally allows firms 15 business days to provide a response to the FDA 483 observations. If FDA receives a response to FDA 483 observations within 15 business days after the FDA 483 was issued, they will conduct a detailed review of the response before determining whether to take any regulatory actions.

When deciding how to respond to FDA, form a cross-functional committee immediately to formulate responses. Responses should be as specific as possible. If there is more than one part to the observation, respond to each part. The response to the FDA 483 should also include corrections to any inaccurate statements in the FDA 483. Demonstrate, if possible, how and why the existing systems in question are in conformance with GLP/GMP and, therefore, not deficient. Provide a corrective action in the response and a realistic timetable for the completion for the corrective actions.

 Inspection Outcome

The FDA inspection outcome of a firm can have substantial impact on the business operations of the company. The FDA inspections may be classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI) in the increasing severity order depending on the outcome. When no Form FDA 483 ‘Inspectional Observations’ is issued, the inspection is classified as NAI. When a Form FDA 483 is issued, it may be classified as VAI or OAI depending on the significance and severity of the deficiencies. OAI classifications may lead to further regulatory actions including Regulatory Meetings, Untitled Letters, Warning Letters, Import Alerts, Injunctions and Seizures. Irrespective of the classification, each inspection will have an Establishment Inspection Report (EIR) written by the FDA investigator and a copy will be sent to the firm as per FMD-145 (Field Management Directive). The investigators are also expected to report significant discussions with the firm management in the EIR.

The contributions of qualified consultants in the post-inspectional phase cannot be understated. Not only can a 3^rd party consultant help with a 483 response, those with ex-FDA experience can also “read between the lines” with FDA’s responses and help a firm craft their response in a way that is strategic and answers FDA’s concerns that might have remained unvoiced in an official document. In addition, a good consulting firm can help your firm strategize how to respond to an adverse inspectional outcome, as well as advise on actionable commitments to discuss with FDA during follow up meetings. In short, the contributions of a well established consulting firm are well worth their price, as the consequences of a poor inspectional outcome are more than just fiscal, they are reputational as well, and long lasting.

For more information on how Lachman Consultants can help your firm prepare for an inspection, assist with an inspection, or help with a response to FDA, please contact the author at T.Arasu@LachmanConsultants.com