FDA Form 483 Database

Right here. The Atlas Form 483 database lets you search 483 reports by company, facility, investigator, product area, and year, and each report opens with its observations, the regulations cited, and the investigators who issued it. A recent example is the Form 483 issued to Silgan Unicep Packaging in Spokane in April 2026, with eight observations.

Search the company or facility name above, then narrow it by year or product area. Every result links to the facility's page, where all of its 483s sit in one inspection history, and a recurring citations section shows whether the same regulations keep coming back. You can also start from the FDA facility lookup and search by company or city.

A Form 483 lists, in numbered observations, the conditions an FDA investigator saw during an inspection that may violate FDA requirements, along with the facility, the inspection dates, and the investigators who signed it. It is not a final finding. FDA classifies the inspection afterwards as NAI, VAI, or OAI, which our guide to NAI, VAI, and OAI classifications explains.

Fifteen business days. There is no legal requirement to respond, but FDA considers responses received within 15 business days of the 483's issue date before deciding whether to send a warning letter. A response that holds up acknowledges each observation, finds the root cause, and commits to dated corrective actions, as our Form 483 response guide shows.

FDA reviews the 483, the investigator's report, and the company's response, then classifies the inspection. Many inspections that end with a 483 are classified VAI, with no regulatory action. An OAI classification can lead to a warning letter and, for a foreign facility, an import alert. Each facility page here shows which of its inspections ended in a warning letter.