Atlas

Form 483

Omnilife Manufactura S.A. de C.V. Form 483, 2012-11-27

FDA issued a Form 483 to Omnilife Manufactura S.A. de C.V. on 2012-11-27 with 2 public-safe observations.

483· Form 483 issued2 observations

Omnilife Manufactura S.A. de C.V. · Tlaquepaque, Mexico · Issued November 27, 2012

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.

27 Nov 2012
21 CFR 111.77(a)

Specifications not met - reject, quality control

Cited by Edward P Potter

27 Nov 2012
21 CFR 111.210(h)(3)(ii)(B)

Components; add, verify

Cited by Edward P Potter

Inspected site

OMOmnilife Manufactura S.A. de C.V.Tlaquepaque, Mexico

Inspection team

EPEdward P Potter

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.210(h)(3)(ii)(B)Cited across public-safe Form 483 observations1x
21 CFR 111.77(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