Atlas

Form 483

Hell On The Red, Inc Form 483, 2010-12-14

FDA issued a Form 483 to Hell On The Red, Inc on 2010-12-14 with 2 public-safe observations.

483· Form 483 issued2 observations

Hell On The Red, Inc · Telephone, United States · Issued December 14, 2010

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.

14 Dec 2010
21 CFR 114.80(a)(1)

Scheduled process

Cited by Jeffrey R Wooley, Yaw O Osei

14 Dec 2010
21 CFR 114.80(a)(4)

Container testing

Cited by Jeffrey R Wooley, Yaw O Osei

Inspected site

HOHell On The Red, IncTelephone, United States

Inspection team

JRJeffrey R Wooley
YOYaw O Osei

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(4)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