Seven Strategies for Avoiding a 483

Updated January 18, 2017

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In-Person Ways to Avoid Form 483 Observations and Warning Letters - MDDI

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Seven Strategies for Avoiding a 483:  'via Blog this'

"What a 483 is — and isn’t. After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit."

A nice, quick and easy primer on 483s.

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The FDA on Gluten-Free Food Labeling

FDA Consumer Updates; A Glimpse at 'Gluten-Free' Food Labeling:  'via Blog this'

Whether as muffins, rolls, or loaves, wheat bread is found in most households. But few consumers may appreciate the substance that helps the dough rise, keeps the bread from falling apart, makes it chewy, and adds to its flavor.

That substance is gluten. Breads, cakes, cereals, pastas, and many other foods are made with wheat or added wheat gluten to improve their baking quality and texture.

Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley, and crossbreeds of these grains and that can harm people who have celiac disease. The only treatment for this disorder is a life-long gluten-free diet.


FDA Press Announcements; FDA reopens comment period on proposed ‘gluten-free’ food labeling rule:

The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.

One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more gluten. The agency based the proposal, in part, on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20 ppm. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries.

“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”

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FDA Says - Unwise To Ignore Form 483

I've taken for granted that no one would intentionally want to ignore an FDA Form 483. But just in case you thought about it, you'll want to reconsider. Read this Outsourcing-Pharma post, "Ignore a form 483? Not wise say FDA." Bottomline, doing nothing increases the likelihood of receiving a warning letter. In summary the FDA believes that “a well-reasoned, complete, and timely 483 response is in your best interest”. 

Related Posts: Medical Device Sponsors - FDA Trends and Tips To Avoid 483s More FDA 483 Resources - Comments and Pearls from Validation Online FDA 483 Inspectional Observations - learn from these examples 

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More FDA 483 Resources - Comments and Pearls from Validation Online

Check this out. More resources on how to apply learnings gleaned from FDA 483s. This particular resource can be found on the Validation-Online.net website. In particular, there's a nice collection of "cGMP FDA 483 COMMENTS." Here you'll find over 100 FDA 483 topics that cover a 483 issue with associated comments, tips, and recommendations. Validation Online says, "Some of the problems listed below cost companies million of dollars to find and rectify."

Previous FDA 483 Posts:
The Health, Drug, Prescription, and GMP Supersite: FDA 483 Inspectional Observations - learn from these examples

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FDA 483 Inspectional Observations - learn from these examples

• FDA cGMP QSR GMP Online Training - respected cGMP online training classes offered by SkillsPlus International Inc.

Here's a small collection of 483s (FDA Form 483 Inspectional Observations). If you've never seen one before, here's your chance. Take advantage of these to learn and share, so that you can avoid getting your own 483s. You can view these on the FDA's website, in the FDA Office of Regulatory Affairs (ORA) Electronic Reading Room. They display copies of ORA records. ORA makes these records publicly available either (1) proactively at their discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information.

According to GMP Trends Inc., "an FDA 483 is a form used by an FDA investigator following an inspection of your plant. It lists deficiencies in your quality system and potential non-compliance issues with GMP's. These observations are based on the investigators interpretation of the GMP regulations as they apply to your specific situation. During the investigator's closing meeting with management, you may be given a Form 483." You can learn more about the FDA's thinking on 483s by reading this section from one of their manuals, FDA Investigations Manual - Reports of Observations.

These 483s can do several things for you. They'll:

1. Get you more familiar with what a 483 is all about
2. Give you the willies so you'll never want to earn your own 483s
3. Provide examples that you can incorporate into your GMP training efforts

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