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Form 483

Worldwide Clinical Trials Early Phase Services Form 483, 2018-10-17

FDA issued a Form 483 to Worldwide Clinical Trials Early Phase Services on 2018-10-17 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Worldwide Clinical Trials Early Phase Services · San Antonio, United States · Issued October 17, 2018

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

17 Oct 2018
21 CFR 312.60

FD-1572, protocol compliance

Cited by Joel Martinez, Johann M Fitch

Inspected site

WCWorldwide Clinical Trials Early Phase ServicesSan Antonio, United States

Inspection team

JMJoel Martinez
JMJohann M Fitch

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

Every observation in full, 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