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FDA Inspection
•Omnilife Manufactura S.A. de C.V.•August 31, 2009

Omnilife Manufactura S.A. de C.V. – FDA Inspection, Aug 31, 2009

Record Details

This FDA Inspection record concerns Omnilife Manufactura S.A. de C.V., with an inspection on August 31, 2009, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Omnilife Manufactura S.A. de C.V.
Inspection Date
August 31, 2009
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 62b77128-041e-4ac7-86e9-9bd77a930713

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
614261
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards

FDA Citations

10
  1. 21 CFR 111.80(a)Components packaging, labels received
  2. 21 CFR 111.75(a)(2)Component - confirm identity; specifications met
  3. 21 CFR 111.315(b)Sampling plans; establish, follow
  4. 21 CFR 111.353Manufacturing operations - written procedures
  5. 21 CFR 111.165(d)(1)Product received - identify
  6. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  7. 21 CFR 111.155(c)Components - quarantine
  8. 21 CFR 111.30(c)Equipment - automated - calibrate, inspect
  9. 21 CFR 111.27(a)(5)(ii)Refrigerator, freezer - alarm
  10. 21 CFR 111.105(f)Quality control - representative samples

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Omnilife Manufactura S.A. de C.V.

2
DateClassificationOfficeProject area
December 6, 2018VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
November 27, 2012VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Omnilife Manufactura S.A. de C.V.
  • FDA Inspection 1073580 - 2018-12-06
  • FDA Inspection 809078 - 2012-11-27

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