Atlas

Form 483

EMS Acquisition Corp Form 483, 2008-11-06

FDA issued a Form 483 to EMS Acquisition Corp on 2008-11-06 with 2 public-safe observations.

483· Form 483 issued2 observations

EMS Acquisition Corp · Morgantown, United States · Issued November 6, 2008

Overview

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

6 Nov 2008
21 CFR 211.63

Equipment Design, Size and Location

Cited by Vlada Matusovsky, Jeen S Min

6 Nov 2008
21 CFR 211.194(a)(8)

Second person sign off

Cited by Vlada Matusovsky, Jeen S Min

Inspected site

EAEMS Acquisition CorpMorgantown, United States

Inspection team

VMVlada Matusovsky
JSJeen S Min

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited 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