What FDA inspection results mean

When FDA inspects a drug plant, the inspection ends with one of three results. Here's what each means, and what it doesn't.

No problems found NAI: No Action Indicated

Inspectors found no objectionable conditions, or only minor ones that don't call for any follow-up.

Problems found, fixed voluntarily VAI: Voluntary Action Indicated

Inspectors found conditions that don't meet the rules, but FDA isn't prepared to take regulatory action. The company is expected to correct them. This is the most common result for large plants, which have many processes to inspect.

Serious problems, FDA action OAI: Official Action Indicated

Inspectors found significant violations and FDA recommended regulatory action. That can mean a warning letter, an import alert that stops the plant's products at the U.S. border, a recall, or court action. An OAI result is serious, but it's about the plant's conditions at the time, and many plants fix the problems and pass later inspections.

Form 483 observations

At the end of an inspection, the investigator can hand the company a Form FDA 483 listing conditions they observed that may violate the rules: for example, not investigating failed test results, or not cleaning equipment properly. A 483 isn't FDA's final decision. FDA publishes summaries of many of these observations, and plant pages show them as published.

What a result doesn't tell you

• It isn't a rating of the medicine. FDA tests products and reviews manufacturing separately, and recalls are the tool for bad batches.
• No recent inspection isn't a red flag by itself. FDA chooses plants by risk, and time between inspections isn't a measure of quality.
• Inspection data starts in fiscal year 2009 and only covers inspections FDA has posted.

If a result worries you, don't stop taking a medicine on your own. Ask your pharmacist; they can often fill your prescription with another manufacturer's version.