Atlas

Form 483

Omnilife Manufactura S.A. de C.V. Form 483, 2018-12-06

FDA issued a Form 483 to Omnilife Manufactura S.A. de C.V. on 2018-12-06 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Omnilife Manufactura S.A. de C.V. · Tlaquepaque, Mexico · Issued December 6, 2018

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 Dec 2018
21 CFR 111.60(a)

Production, in- process control system - design, quality

Cited by Dariusz Galezowski, Leslie D Hintz

Inspected site

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

Inspection team

DGDariusz Galezowski
LDLeslie D Hintz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.60(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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