FDA Inspection
Benuvia Operations, LLCBenuvia Operations, LLC – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns Benuvia Operations, LLC, with an inspection on February 16, 2018, issued by the Dallas District Office, covering human drugs.
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ID · ed1454a9-9b42-4611-93a4-1262667b4058
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041504
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Benuvia Operations, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2026 | Not classified | Dallas District Office | Drug Quality Assurance |
| September 20, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 12, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Benuvia Operations, LLC
- FDA Inspection 1283450 - 2026-01-23
- FDA Inspection 1156279 - 2021-09-20
- FDA Inspection 1026313 - 2017-09-12
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