FDA compliance program
PRE-APPROVAL INSPECTIONS - BIOSIMILARS
FDA program assignment code 52832S · Drugs (CDER)
Key facts
| Program assignment code (PAC) | 52832S |
|---|---|
| Program | PRE-APPROVAL INSPECTIONS - BIOSIMILARS |
| FDA center | Drugs (CDER) |
| Program area and operations | Domestic Inspections, Generic Drug Evaluation, INSPECTION (PRE MARKET APPROVAL) PRE LICENSE |
At a glance
- 1–9 FDA inspections under this program
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA compliance programs (program assignment codes)
FDA inspections and field assignments are planned under compliance programs. Each one is coded with a program assignment code (PAC) that ties it to a program in the FDA Compliance Program Guidance Manual (CPGM).
Source: U.S. Food and Drug Administration (FDA), Compliance Program Guidance Manual and inspection data
Browse all FDA compliance programs (program assignment codes)