What to Expect After the Inspection


Close-out Letters: What They Are and What They Mean

A Warning Letter close-out letter ("close-out letter") will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA Read More

483s and EIRs: What They Are and What They Mean

Receiving a Form 483—a communication that alerts a company to observations found in an inspection—is a critical turning point in an inspection, as the 483 and the company’s response will determine whether the agency escalates its enforcement actions to a warning letter. Read More

Responding to 483s

There is no regulatory requirement for a company to respond to a Form 483. However, it is in a company’s best interest to respond in writing to those inspection observations. Read More

Warning Letters: What They Are and What They Mean

The warning letter, which may or may not follow the issuance of a Form 483 (a form that details observations found in an inspection so a company can address them) is an informal advisory to a company communicating the agency’s position on a matter but does not commit the FDA to further enforcement action. Read More

Responding to Warning Letters

The FDA expects responses to warning letters within 15 business days. Preparing comprehensive, persuasive responses to FDA findings are critical to a company’s success in regaining a positive compliance profile. Read More

Working with Regulators to Resolve Deficiencies

It is important that a company work with regulators to resolve any deficiencies that are uncovered in an inspection. Obviously, a company will want to respond to any 483s or warning letters. Read More

Corporate Integrity Agreements: What They Are and What They Mean

Corporate integrity agreements (CIA) are documents that outline the specific obligations a company agrees to as part of a civil settlement. Read More

Injunctions: What they are and what they mean

An injunction may be considered for any significant out-of-compliance circumstance, but particularly when a health hazard has been identified. Read More