Avole, Inc., San Sebastian, PR – FDA Inspections

Inspection records and compliance data for Avole, Inc. in San Sebastian, Puerto Rico. 8 FDA inspections on record, 2 Form 483s, last inspected September 13, 2024.

Company Profile

This profile covers Avole, Inc. based in San Sebastian, Puerto Rico, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 5
NAI: 3
Form 483s: 2
Warning letters: 0

First inspected July 23, 2009. Last inspected September 13, 2024.

Most cited issue areas

HACCP plan implementation2 inspections
Food safety hazards1 inspection
HACCP training or qualification1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
September 13, 2024	NAI	Foods & Cosmetics · Food Composition, Standards, Labeling, and Economics	1249386
September 30, 2021	NAI	Foods & Cosmetics · Food Composition, Standards, Labeling and Econ	1153978
February 21, 2018	VAI	Foods & Cosmetics · Food Composition, Standards, Labeling and Econ	1041836
March 20, 2015	VAI	Foods & Cosmetics · Food Composition, Standards, Labeling and Econ	918159
December 12, 2013	VAI	Foods & Cosmetics · Foodborne Biological Hazards	857316
June 14, 2012	VAI	Foods & Cosmetics · Foodborne Biological Hazards	786523
June 2, 2011	NAI	Foods & Cosmetics · Food and Color Additives Petition Review	728438
July 23, 2009	VAI	Foods & Cosmetics · Foodborne Biological Hazards	601117

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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