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FDA Inspection
•Essential Flavors & Fragrances, Inc.•July 6, 2010

Essential Flavors & Fragrances, Inc. – FDA Inspection, Jul 6, 2010

Record Details

This FDA Inspection record concerns Essential Flavors & Fragrances, Inc., with an inspection on July 6, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Essential Flavors & Fragrances, Inc.
Inspection Date
July 6, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 40984380-c75d-4920-bc09-a8380950ffb9

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
675280
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

9
  1. 21 CFR 211.188Prepared for each batch, include complete information
  2. 21 CFR 211.25(a)Training--operations, GMPs, written procedures
  3. 21 CFR 211.198(a)Procedures to be written and followed
  4. 21 CFR 211.130Procedures are written, and followed
  5. 21 CFR 211.165(a)Testing and release for distribution
  6. 21 CFR 211.84(d)(1)Identity Testing of Each Component
  7. 21 CFR 211.100(a)Absence of Written Procedures
  8. 21 CFR 211.22(a)Lack of quality control unit
  9. 21 CFR 211.67(b)Written procedures not established/followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Essential Flavors & Fragrances, Inc.

3
DateClassificationOfficeProject area
March 7, 2022NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
October 25, 2017NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
April 5, 2012NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
Other documents for Essential Flavors & Fragrances, Inc.
  • FDA Inspection 1166361 - 2022-03-07
  • FDA Inspection 1032054 - 2017-10-25
  • FDA Inspection 775602 - 2012-04-05

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