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FDA Inspection
•Ozona Organics LLC•December 16, 2021

FDA Inspection 1158969 - Ozona Organics LLC - December 16, 2021

Record Details

This FDA Inspection record concerns Ozona Organics LLC, with an inspection on December 16, 2021, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Ozona Organics LLC
Inspection Date
December 16, 2021
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · d06a066a-dd46-48ef-8cbf-c427016afcaf

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1158969
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

12
  1. 21 CFR 117.80(b)(2)Raw materials control - Microorganisms
  2. 21 CFR 111.70(b)(1)Specifications - component identity
  3. 21 CFR 111.70(b)(3)Specifications - contamination limits
  4. 21 CFR 111.70(e)Specifications - contamination limits
  5. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  6. 21 CFR 111.255(a)Batch record - every batch
  7. 21 CFR 111.205(a)Master manufacturing record - each batch
  8. 21 CFR 507.25(c)(2)Manufacturing, Processing, Packing, Holding - Measures
  9. 21 CFR 111.25(c)Procedures - equipment - cleaning, sanitizing
  10. 21 CFR 111.103Written procedures - quality control operations

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ozona Organics LLC

1
DateClassificationOfficeProject area
June 29, 2023VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Ozona Organics LLC
  • FDA Inspection 1209458 - 2023-06-29

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