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FDA Inspection
•Alora Pharmaceuticals•April 13, 2026

Alora Pharmaceuticals – FDA Inspection, Apr 13, 2026

Record Details

This FDA Inspection record concerns Alora Pharmaceuticals, with an inspection on April 13, 2026, issued by the Atlanta District Office, covering human drugs.

Company
Alora Pharmaceuticals
Inspection Date
April 13, 2026
Product Type
Human Drugs
Office
Atlanta District Office
People
  • Pratik S. Upadhyay (FDA Associated Person)
  • Samantha E. Cleek (Investigator)
  • Veronica Fuentes (FDA Associated Person)
View Company Profile

ID · 38a374e9-b736-4d83-9e61-6551e192e337

Inspection Facts

Inspection number
1312272
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 211.166(a)Lack of written stability program
  2. 21 CFR 211.166(a)Written program not followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Alora Pharmaceuticals

4
DateClassificationOfficeProject area
March 29, 2019VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
December 21, 2017NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 11, 2017NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
March 8, 2017VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for Alora Pharmaceuticals
  • FDA Inspection 1085822 - 2019-03-29
  • FDA Inspection 1048852 - 2017-12-21
  • FDA Inspection 1028389 - 2017-09-11
  • FDA Inspection 1014708 - 2017-03-08

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