FDA-Inspected Site

BeiGene, USA Inc.

1 FDA inspection is on record for BeiGene, USA Inc. in San Mateo, United States.

483· Form 483 issued

San Mateo, United States · Last updated July 11, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2023-11-13.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
30 Oct 2023 – 13 Nov 2023Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

13 Nov 2023
21 CFR 312.50

General responsibilities of sponsors

Cited by Scott N Lim

13 Nov 2023
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Scott N Lim

13 Nov 2023
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Scott N Lim

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind BeiGene, USA Inc.'s 1 Form 483

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat