The 483 Solution—What You Need To Know

Posted by Elise Oberliesen on December 14, 2017 at 2:03 PM

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You were served a 483—now what? Anyone who's ever dealt with a 483 knows it's no fun. Gain insight into ways you can take the pain out of dealing with 483s.

Form 483: What is it?

A summary of findings—a list of “objectionable conditions” or “practices” found in a processing facility during an FDA inspection. Is it a big deal? The short answer—yes.

After receiving a 483, you can usually expect the Establishment Inspection Report (EIR) to follow. It provides more details about the inspector’s findings during the audit and is usually issued within 30 days post inspection.

EIR Communicates Next Steps:

  • NAI-No Action Required
  • VAI-Voluntary Action Indicated
  • OAI-Official Action Indicated

2500—That’s the average number of 483s food companies receive annually, a finding reported in Food Safety Tech Magazine. In dire circumstances, like finding microorganisms, it can lead to lost production, a costly recall, or worse, a scar to the brand’s reputation.

It is well documented that inspectors can take test samples from just about anywhere in the facility, even if it’s not a direct food contact surface. That's because certain microorganisms could still potentially pose a threat of contamination, even in zones further away from direct food contact surfaces. 

Inspection citations come in all shapes and sizes—some minor, others, not so much. From inadequate sanitation procedures and poor record keeping, to questionable pH levels found in food samplesthere's no telling what the inspectors will find when they pay you a visit.

So we did a little digging to get an idea about various citations issued to food companies in the United States by FDA inspectors.  Do any of these look familiar? If you can relate to any on the list, your company could land on the 483 short list.

These are a few offenses taken straight from the FDA Inspections Citations Dataset:

  1. Suitable outer garments that protect against contamination of food and food contact surfaces.
  2. The procedure used for cleaning and sanitizing of equipment has not been shown to provide adequate cleaning and sanitizing treatment.
  3. You did not exclude pests from your food plant to protect against contamination of food.
  4. You did not have allergen controls monitoring records.
  5. You did not implement the monitoring, recordkeeping, and verification procedures listed in your HACCP.
  6. Failure to exercise sufficient control including frequent testing and recording of results so that the finished equilibrium pH values are not higher than 4.6.
  7. Your quality control operations did not include reviewing and approving all records for packaging and label operations.
  8. You did not establish a corrective action plan to use when an established specification is not met.
  9. You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations.

A Few Tips When Working With Inspectors

Whether an inspector writes you up for one objectionable condition, or 14, once you’re staring down at the dreaded 483, the FDA has you at full attention.  Here are a few ways to resolve 483s with glowing confidence.

First, thoroughly review the 483 with the inspector onsite, suggests Marc Sanchez, Attorney who represents FDA-regulated companies, and works as an Adjunct Professor at Northeastern University.  If you disagree with the inspector’s interpretation or findings during an inspection, it’s important to speak up, suggests Sanchez.

“Because once you consent, it’s done, there’s no ability to later delay or challenge that,” says Sanchez.  “Make sure you understand what you are consenting to.”

If you decide to raise a legitimate objection, remember that appearances matter.  Do not give the impression that you have impeded, delayed or refused the inspection, a suggestion from Sanchez. 

The goal of the inspection is that the inspector writes up an accurate 483one that represents operations at the facility, says Sanchez. To the best of your ability, clear up confusion so that the inspector’s observations are true and accurate, something Sanchez continually emphasizes when discussing this matter.

How do you do that? Open up a discussion. Ask questions to help clarify findings and gauge their interpretations.

Upon Completion Of The Inspection

  1. Continue to maintain communication with the FDA.
  2. Respond to the FDA in writing.
  3. Provide the corrective action plan you created to solve any potential problems. Then put those plans into action.

Depending on the severity and what the FDA reported in the 483, you may receive a warning letter.  If you do, respond in a timely manner. Currently, the FDA indicates that you must respond within 15 days. 

To find out how to conduct yourself during an inspection, listen to the webinar entitled “You Gotta Fight For Your Rights (During an FDA Inspection).” If you've ever dealt with a 483we're pretty sure you have some colorful stories to tell. Please share any tips or suggestionsthis is your chance to dish in the comment section below.  

 

Tags: FDA, TraceGains, Food Safety, food product manufacturers, EIR, 483, form 483, corrective actions, Establishment Inspection Report, warning letter