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FDA Inspection
•Vitality Works, Inc•August 5, 2022

Vitality Works, Inc – FDA Inspection, Aug 5, 2022

Record Details

This FDA Inspection record concerns Vitality Works, Inc, with an inspection on August 5, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Vitality Works, Inc
Inspection Date
August 5, 2022
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 538fc1b2-4699-492b-8ac2-af6c67270b5f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1177119
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

7
  1. 21 CFR 211.84(d)(2)Component written specification
  2. 21 CFR 211.25(a)Training , Education , Experience overall
  3. 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
  4. 21 CFR 211.180(e)Records reviewed annually
  5. 21 CFR 211.100(a)Absence of Written Procedures
  6. 21 CFR 211.22(d)Procedures not in writing, fully followed
  7. 21 CFR 211.192Written record of investigation incomplete

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Vitality Works, Inc

5
DateClassificationOfficeProject area
February 24, 2025Not classifiedDenver District Office
August 8, 2019NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
June 15, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 6, 2015NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 22, 2011NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Vitality Works, Inc
  • FDA Inspection 1250700 - 2025-02-24
  • FDA Inspection 1101020 - 2019-08-08
  • FDA Inspection 974120 - 2016-06-15
  • FDA Inspection 951664 - 2015-11-06
  • FDA Inspection 730989 - 2011-06-22

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