Form 483

Pegasus Research Corporation Form 483, 2021-04-07

FDA issued a Form 483 to Pegasus Research Corporation on 2021-04-07 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Pegasus Research Corporation · Santa Ana, United States · Issued April 7, 2021

Overview

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

Inspectional observations

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

7 Apr 2021
21 CFR 820.30(a)

Design control - no procedures

Cited by Kevin N Tran

7 Apr 2021
21 CFR 820.30(a)

Design control - no procedures

Cited by Kevin N Tran

Inspected site

PRPegasus Research CorporationSanta Ana, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(a)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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