Managing the Inspection

ARTICLES

How the FDA Inspection Process Works

To manage FDA inspections, you need to understand how inspections are carried out. Read More

Deciding Whether to Let FDA Inspectors into Your Facility

Despite these broad inspection powers, you can make the decision not to allow an FDA investigator into your facility. But while it is your legal right, denying entrance to an FDA investigator is risky and rarely advisable. Read More

Should/Can You Refuse to Let FDA Investigators Take Samples?

FDA inspection powers include the right to collect samples of raw materials and finished products. Read More

Should/Can You Refuse to Let FDA Investigators Take Photographs?

Although FDA inspectors have very broad powers, whether they have the right to take photos during an inspection is not 100 percent clear. FDA photography can be a controversial issue. Read More

Responding to Record Requests

FDA has distinct authority under section 704(e) of the FD&C Act [21 U.S.C. 374 (e)] to inspect and copy records required under section 519 or 520(g) of the FD&C Act. Read More

The Keys to Effective Subject Matter Expert Interviews

The law does not expressly say that the FDA can conduct interviews. But the FDA considers interviews to be part of an inspection conducted "within reasonable limits and in a reasonable manner" and routinely carries them out during inspections. Read More

Responding to Concerns Raised During Inspection

The FDA 483 Inspectional Observations form is intended for use in notifying the inspected establishment's top management in writing of significant objectionable conditions Read More