Atlas

Form 483

A.M. Surgical, Inc. Form 483, 2010-10-15

FDA issued a Form 483 to A.M. Surgical, Inc. on 2010-10-15 with 2 public-safe observations.

483· Form 483 issued2 observations

A.M. Surgical, Inc. · Smithtown, United States · Issued October 15, 2010

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

15 Oct 2010
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Kwong P Lee

15 Oct 2010
21 CFR 820.70(a)

Production processes

Cited by Kwong P Lee

Inspected site

ASA.M. Surgical, Inc.Smithtown, United States

Inspection team

KPKwong P Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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