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FDA Inspection
•PhytogenX, Inc.•February 10, 2020

PhytogenX, Inc. – FDA Inspection, Feb 10, 2020

Record Details

This FDA Inspection record concerns PhytogenX, Inc., with an inspection on February 10, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
PhytogenX, Inc.
Inspection Date
February 10, 2020
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 09e986c7-c20d-4cb9-b18b-52e14a0ee634

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1117358
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.160(a)Following/documenting laboratory controls
  2. 21 CFR 211.192Investigations of discrepancies, failures
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of PhytogenX, Inc.

5
DateClassificationOfficeProject area
March 27, 2025VAIPhiladelphia District OfficeDrug Quality Assurance
June 6, 2023NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
February 14, 2019VAICenter for Devices and Radiological HealthCompliance: Devices
July 31, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 30, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for PhytogenX, Inc.
  • FDA Inspection 1265048 - 2025-03-27
  • FDA Inspection 1208087 - 2023-06-06
  • FDA Inspection 1079308 - 2019-02-14
  • FDA Inspection 935526 - 2015-07-31
  • FDA Inspection 682008 - 2010-09-30

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