Question 1

What is an FDA inspection citation?

Accepted Answer

An inspection citation is the specific legal reference — a section of the Code of Federal Regulations (CFR) or the Food, Drug, and Cosmetic (FD&C) Act — that an inspection observation maps to. Where a Form 483 observation is written in narrative form, a citation pins it to the exact requirement at issue (for example, 21 CFR 211.22 for quality-unit responsibilities), which is what makes citation data searchable and comparable across firms.

Question 2

How is a citation different from a Form 483 observation?

Accepted Answer

A Form 483 observation is the investigator’s written description of what was found at a facility. A citation is the structured regulatory reference behind it, drawn from the FDA Data Dashboard. One inspection can generate several 483 observations and several citations, and the citation data is what lets you ask questions like "which firms were cited under 21 CFR 211 this year" rather than reading each 483 narrative individually.

Question 3

What do CFR references like "21 CFR 211.100" mean?

Accepted Answer

CFR references identify the regulation an observation relates to: the title (21 is Food and Drugs), the part (211 is current Good Manufacturing Practice for finished pharmaceuticals), and the section/subsection (211.100 covers written production and process control procedures). Other common parts include 21 CFR 820 (the Quality System Regulation for medical devices), 606 (blood), and 111 (dietary supplements). This index parses each citation into title, part, and section so you can filter and group by them.

Question 4

What is the FD&C Act, and how is it cited?

Accepted Answer

The Federal Food, Drug, and Cosmetic (FD&C) Act is the underlying statute that authorizes the FDA and its regulations. Some inspection citations reference sections of the Act itself rather than a CFR part — for example, adulteration or misbranding provisions. This index distinguishes CFR citations from FD&C Act citations so each is searchable in its own right.

Question 5

How do citations connect to inspections and Form 483s?

Accepted Answer

Each citation belongs to a specific inspection (by inspection ID) and rolls up to the firm (by FEI). That lets you trace a citation back to the inspection that produced it, see the inspection’s classification, and find related published 483 records for the same firm — moving from a single regulatory reference to the full inspection and firm context in a few clicks.

Question 6

Why might this citation index look empty right now?

Accepted Answer

Inspection citation data comes from the credentialed FDA Data Dashboard feed. When that feed is connected, citations populate and become searchable here automatically; until then, this dedicated citation index can be empty even though the published Form 483 records and firm history are already live. We deliberately show an empty index rather than placeholder data so nothing here misrepresents the FDA’s record.