Form 483

American Contract Systems, Inc. Form 483, 2019-10-04

FDA issued a Form 483 to American Contract Systems, Inc. on 2019-10-04 with 22 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health22 observations

American Contract Systems, Inc. · Houston, United States · Issued October 4, 2019

Overview

  • 22 public-safe observations are available for this inspection.
  • 5 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.

4 Oct 2019
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Jocelyn C Turner

4 Oct 2019
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Jocelyn C Turner

4 Oct 2019
21 CFR 820.70(i)

Software validation for automated processes

Cited by Jocelyn C Turner

4 Oct 2019
21 CFR 820.70(i)

Software validation for automated processes

Cited by Jocelyn C Turner

4 Oct 2019
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Jocelyn C Turner

Inspected site

ACAmerican Contract Systems, Inc.Houston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.181Cited across public-safe Form 483 observations6x
21 CFR 820.75(a)Cited across public-safe Form 483 observations6x
21 CFR 820.75(b)Cited across public-safe Form 483 observations6x
21 CFR 820.70(i)Cited across public-safe Form 483 observations2x
21 CFR 820.75(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 22 observations

The full inspection record, as Atlas holds it, 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