Form 483

WCCT Global, LLC Form 483, 2021-06-18

FDA issued a Form 483 to WCCT Global, LLC on 2021-06-18 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

WCCT Global, LLC · Cypress, United States · Issued June 18, 2021

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

18 Jun 2021
21 CFR 312.57(a)

Records of receipt, shipment, disposition

Cited by Andrea A Branche, Kaitlyn T Dang

18 Jun 2021
21 CFR 312.60

FD-1572, protocol compliance

Cited by Andrea A Branche, Kaitlyn T Dang

Inspected site

WGWCCT Global, LLCCypress, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.57(a)Cited across public-safe Form 483 observations1x
21 CFR 312.60Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere