You received a 483? Don’t Panic…

An FDA Inspection

So you’ve been visited by the FDA and whether you’re a seasoned QA manager at a major pharmaceutical manufacturer or the pharmacist in charge of a small compounding pharmacy you’ll more than likely receive (or have received) a 483 form after the visit. It’s how you respond that decides if any further action by the FDA will take place.

FDA Form 483

A 483 is simply the agency’s way of documenting and notifying a firm’s management of observations made during an inspection. Typically, the observations are significant enough for an inspector to document when they have noticed something that would cause the firm’s products to be adulterated and/or bring harm to the public. However, the 483 is not meant to be all inclusive; meaning there may be other issues with the facility that the inspector hasn’t noted. The inspections are pre-planned and conducted with a particular focus in mind. If there’s been a specific complaint or publicly known issue then the inspection may be very targeted on certain aspects of the operation.

This leads to the two types of inspections that the FDA conducts: full and abbreviated. A new firm opening its doors for the first time will receive a full inspection as well as previously inspected manufacturers that have had significant deficiencies from abbreviated inspections. A full inspection is a top to bottom inspection of most of the major systems the FDA monitors (more on those systems in a bit). An abbreviated inspection is warranted only when a firm has previously demonstrated that they have an ongoing record of compliance and has implemented a risk management program in their manufacturing operation.

The Basis for 483 Observations

I’ll be touching on this in subsequent posts but a brief explanation for why your firm received a 483 is based on adherence to the FDAs Quality Systems approach to manufacturing. The takeaway here is that you have control over the six main systems the FDA observes: the Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling and Laboratory Control systems. The key is in how you demonstrate and maintain control over each of these systems. I’ll go into greater detail on this in the very near future.

Responding to a 483

One of the most important things about your response to the FDA is the timeliness. You MUST respond, in writing, within 15 days from the receipt of the form 483. In your response be sure to include:

  • restatement of the issue
  • activities being pursued to contain the issue
  • root cause investigation (if necessary)
  • actions taken to prevent recurrence
  • documented evidence of corrective measures
  • verification of effectiveness of corrective measures

More than likely, if your response is well written with a good action plan for remediation and a timeline for completion, your chances of receiving a warning letter will be greatly reduced. A best practice to illustrate your action plan on a timeline is to provide the agency with a Gantt chart with your response. This gives the agency a visual timeline for correcting all of the observations from the 483.

A final note and useful tools

If you’re going to include a nice, fancy Gantt chart with a timeline of corrections be sure to make the necessary changes in a timely fashion but be realistic. Whatever you do, DON’T overpromise and under deliver. This is the quickest way to receive follow up actions (i.e. warning letter).

Here are two gantt chart templates; one from google docs and the other is for excel:

Google Sheets Gantt Chart Template 

Excel Gantt Chart Template

About the Author:

Seth DePasquale is a board certified sterile compounding pharmacist and former co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.

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  1. I know from experience that a visit from the FDA can be stressful and time consuming. When it comes to timelines, I would suggest painting with a broader brush instead of giving the agency a detailed timeline. Fifteen days is not a lot of time to formulate a concrete plan. Especially considering you probably just lost 5-10 work days to the inspection. If you do not hit your deadlines, the best practice would be to update the agency before that deadline has passed. If things snowball, then you wind up apologizing a lot. Experiencing this problem a colleague asked for guidance from an FDA auditor regarding what their expectations were. He advised that the FDA is most concerned with documented completion of the tasks outlined in the response letter. Instead of giving specific dates, he suggested giving deadlines by quarters (i.e. first quarter of 2022) and keeping the detailed timeline as an internal document. I used this strategy in subsequent interactions with the agency without incident.