Form 483

White Egret, Inc. Form 483, 2009-11-04

FDA issued a Form 483 to White Egret, Inc. on 2009-11-04 with 3 public-safe observations.

483· Form 483 issued3 observations

White Egret, Inc. · Ogden, United States · Issued November 4, 2009

Overview

3 public-safe observations are available for this inspection.
3 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.

4 Nov 2009

21 CFR 803.17

Lack of Written MDR Procedures

Cited by Ginger M Sykes, Neira Acevedo-Ramos

4 Nov 2009

21 CFR 820.20

Management responsibility

Cited by Ginger M Sykes, Neira Acevedo-Ramos

4 Nov 2009

21 CFR 820.75(a)

Documentation

Cited by Ginger M Sykes, Neira Acevedo-Ramos

Inspected site

WEWhite Egret, Inc.Ogden, United States

Inspection team

GMGinger M Sykes

NANeira Acevedo-Ramos

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 803.17	Cited across public-safe Form 483 observations	1x
21 CFR 820.20	Cited across public-safe Form 483 observations	1x
21 CFR 820.75(a)	Cited across public-safe Form 483 observations	1x

Full 483 report

Get the verbatim text of all 3 observations

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