Atlas

Form 483

ALS Group USA Corp Form 483, 2017-02-06

FDA issued a Form 483 to ALS Group USA Corp on 2017-02-06 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

ALS Group USA Corp · Houston, United States · Issued February 6, 2017

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.

6 Feb 2017
21 CFR 211.182

Personnel dating/signing equipment log

Cited by Camerson E Moore

6 Feb 2017
21 CFR 211.194(a)(8)

Second person sign off

Cited by Camerson E Moore

Inspected site

AGALS Group USA CorpHouston, United States

Inspection team

CECamerson E Moore

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)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