FDA Inspection
Aphena Pharma Solutions - Tennessee LLCAphena Pharma Solutions - Tennessee LLC – FDA Inspection, Nov 16, 2017
Record Details
This FDA Inspection record concerns Aphena Pharma Solutions - Tennessee LLC, with an inspection on November 16, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cab1c194-a13e-4e74-83f5-9d05cf291828
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1031560
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
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Other FDA inspections of Aphena Pharma Solutions - Tennessee LLC
14| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2025 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 30, 2024 | Not classified | New Orleans District Office | |
| August 30, 2023 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 25, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 9, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aphena Pharma Solutions - Tennessee LLC
- FDA Inspection 1295650 - 2025-11-03
- FDA Inspection 1254447 - 2024-10-30
- FDA Inspection 1219353 - 2023-08-30
- FDA Inspection 1176357 - 2022-07-25
- FDA Inspection 1148356 - 2021-07-09
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