FDA Inspection
Alora PharmaceuticalsAlora Pharmaceuticals – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns Alora Pharmaceuticals, with an inspection on March 29, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c4aa737c-7804-4d1a-805b-ec94a1b10c38
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085822
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
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Other FDA inspections of Alora Pharmaceuticals
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2026 | Not classified | Atlanta District Office | Drug Quality Assurance |
| December 21, 2017 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 11, 2017 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 8, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Alora Pharmaceuticals
- FDA Inspection 1312272 - 2026-04-13
- FDA Inspection 1048852 - 2017-12-21
- FDA Inspection 1028389 - 2017-09-11
- FDA Inspection 1014708 - 2017-03-08
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