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FDA Inspection
•Natren, Inc.•November 2, 2023

Natren, Inc. – FDA Inspection, Nov 2, 2023

Record Details

This FDA Inspection record concerns Natren, Inc., with an inspection on November 2, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Natren, Inc.
Inspection Date
November 2, 2023
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Heidy C. Perales (Company Rep)
View Company Profile

ID · c5f00244-fe27-4f81-8037-53cca5893f27

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1221697
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

6
  1. 21 CFR 211.84(a)Components withheld from use pending release
  2. 21 CFR 211.22(a)Approve or reject components, products
  3. 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
  4. 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
  5. 21 CFR 211.22(a)Approve or reject components, products
  6. 21 CFR 211.84(a)Components withheld from use pending release

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Natren, Inc.

7
DateClassificationOfficeProject area
May 31, 2024VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 8, 2019VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
December 21, 2016NAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
September 8, 2015NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 6, 2014NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for Natren, Inc.
  • FDA Inspection 1229562 - 2024-05-31
  • FDA Inspection 1106577 - 2019-10-08
  • FDA Inspection 996806 - 2016-12-21
  • FDA Inspection 941466 - 2015-09-08
  • FDA Inspection 889695 - 2014-08-06

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