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FDA Inspection
•World Club Supply Corp•November 3, 2020

World Club Supply Corp – FDA Inspection, Nov 3, 2020

Record Details

This FDA Inspection record concerns World Club Supply Corp, with an inspection on November 3, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
World Club Supply Corp
Inspection Date
November 3, 2020
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 518c4374-2e46-4a95-8ce0-72d6a406dae4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1132716
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

9
  1. 21 CFR 211.22(b)Adequate lab facilities not available
  2. 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
  3. 21 CFR 211.63Equipment Design, Size and Location
  4. 21 CFR 211.194(a)Complete test data included in records
  5. 21 CFR 211.68(a)Calibration/Inspection/Checking not done
  6. 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
  7. 21 CFR 211.100(a)Absence of Written Procedures
  8. 21 CFR 211.166(a)Lack of written stability program
  9. 21 CFR 211.192Written record of investigation incomplete

Full citation text and observation details available on the Dashboard.

Other FDA inspections of World Club Supply Corp

3
DateClassificationOfficeProject area
August 18, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 13, 2011NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
September 3, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for World Club Supply Corp
  • FDA Inspection 982362 - 2016-08-18
  • FDA Inspection 750705 - 2011-10-13
  • FDA Inspection 682938 - 2010-09-03

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