Atlas

Form 483

Ameritek USA, Inc. Form 483, 2010-09-08

FDA issued a Form 483 to Ameritek USA, Inc. on 2010-09-08 with 4 public-safe observations.

483· Form 483 issued4 observations

Ameritek USA, Inc. · Everett, United States · Issued September 8, 2010

Overview

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

Inspectional observations

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

8 Sep 2010
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Christine M Parmentier

8 Sep 2010
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Christine M Parmentier

8 Sep 2010
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Christine M Parmentier

8 Sep 2010
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Christine M Parmentier

Inspected site

AUAmeritek USA, Inc.Everett, United States

Inspection team

CMChristine M Parmentier

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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