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FDA Inspection
•Exquisite Corporation•August 1, 2024

Exquisite Corporation – FDA Inspection, Aug 1, 2024

Record Details

This FDA Inspection record concerns Exquisite Corporation, with an inspection on August 1, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Exquisite Corporation
Inspection Date
August 1, 2024
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Sara H. Gabel
View Company Profile

ID · 95345e92-b26f-4201-a42b-a6dc10f58cab

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1245264
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

6
  1. 21 CFR 211.63Equipment Design, Size and Location
  2. 21 CFR 211.68(a)Calibration/Inspection/Checking not done
  3. 21 CFR 211.84(d)(2)Component identification test
  4. 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
  5. 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
  6. 21 CFR 211.166(a)(4)Testing in same container - closure system

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Exquisite Corporation

2
DateClassificationOfficeProject area
April 26, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 9, 2013NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
Other documents for Exquisite Corporation
  • FDA Inspection 1205627 - 2023-04-26
  • FDA Inspection 815499 - 2013-01-09

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Contact
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