Resources

Three places to go deeper than this lesson, or to check a citation yourself before it goes into a real Lakeshore document. All three were checked and loading at the time this page was written.

• 21 U.S.C. 374, Cornell Legal Information Institute — the full statutory section this lesson excerpted from. This lesson only quotes (a)(1), (b)(1), (c), and (h)(1)’s opening clause; the full section is long and heavily amended, and worth skimming once to see how much of it this lesson deliberately left out (infant-formula and clinical-study-inspection provisions, among others).

• FDA, Inspection Observations — FDA’s own public page describing Form FDA 483, including where FDA publishes spreadsheets summarizing what gets cited on 483s by fiscal year. Useful for seeing what kinds of observations are common across FDA’s regulated industries generally.

• FDA, “CDER GCP Inspections and Outcomes” (PDF) — the source for this lesson’s NAI/VAI/OAI classification quotes. Read this one with the scope caveat in mind: it’s a presentation specifically about Good Clinical Practice (GCP) inspections of clinical drug trials, not about CGMP inspections of a manufacturing or blood-collection facility. Only its general three-outcome classification scheme (NAI, VAI, OAI) applies beyond that context — its clinical-trial-specific examples and statistics do not.