The Form 483 Solution — What You Need to Know

by | June 1, 2021

Your company received a Form 483. Now what? Anyone who’s ever dealt with a 483 knows it’s no fun. But there is a solution.

Form 483: What is it?

Form 483 is 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 is yes. After receiving a 483, companies can typically expect an Establishment Inspection Report (EIR) to follow. It provides more details about the inspector’s findings during the audit, which they issue within 30 days of the inspection.

EIR Communicates Next Steps:

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

The FDA issued 1,749 Form 483s to food manufacturers in 2020. In dire circumstances, like finding microorganisms, it can lead to lost production, a costly recall, or worse, a scar on the brand’s reputation.

It’s well documented that inspectors can take test samples from anywhere in the facility, even if it’s not a direct food contact surface. Certain microorganisms could 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 are minor, but others can be more serious. From inadequate sanitation procedures and poor recordkeeping to questionable pH levels found in food samples — there’s no telling what inspectors will discover when they visit a plant.

Form 483 Offenses

So, we did a little digging to get an idea about various citations issued to food companies in the United States. If you can relate to any on the list, your company could land on the 483 shortlist.

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

  1. Lack of suitable outer garments that protect against contamination of food and food contact surfaces.
  2. The procedure used for cleaning and sanitizing equipment hasn’t been shown to provide adequate cleaning and sanitizing treatment.
  3. Pests not excluded from the food plant to protect against food contamination.
  4. Lack of allergen controls monitoring records.
  5. No implementation of monitoring, recordkeeping, and verification procedures listed in the HACCP.
  6. Failure to exercise sufficient control, including frequent testing and recording results, so that the finished equilibrium pH values aren’t higher than 4.6.
  7. Quality control operations didn’t include reviewing and approving all records for packaging and label operations.
  8. No established corrective action plan to use when an established specification isn’t met.
  9. No supplier qualification by establishing the reliability of the supplier’s certificate of analysis through the confirmation of the results of their tests or examinations.

Working with inspectors

Whether an inspector writes a company up for one objectionable condition or 14, once a company receives a Form 483, the FDA has taken an interest. There are a few ways to resolve 483s with glowing confidence:

First, thoroughly review the 483 with the inspector on-site, suggests Marc Sanchez, an attorney who represents FDA-regulated companies, and an adjunct professor at Northeastern University. If you disagree with the inspector’s interpretation or findings during an inspection, it’s essential to speak up, Sanchez says.

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

If you decide to raise a legitimate objection, remember that appearances matter. Don’t give the impression that you have impeded, delayed, or refused the inspection, Sanchez advises. 

The goal of the inspection is that the inspector writes up an accurate 483 — one that represents operations at the facility, Sanchez says. To the best of your ability, clear up any confusion, so 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.

After the inspection

  1. Continue to maintain communication with the FDA.
  2. Respond to the FDA in writing.
  3. Provide a corrective action planto address any potential problems. Then put those plans into action.

Depending on the severity and what the FDA reported in the 483, companies might receive a warning letter. If you do, respond promptly. The FDA indicates you must respond to a warning letter within 15 days.

Want to be ready for any audit at any time? For more tips and best practices, download our eBook, “Are You Ready for an Audit” here.

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