FDA Inspection
Unit Dose Services, LLCUnit Dose Services, LLC – FDA Inspection, Apr 26, 2018
Record Details
This FDA Inspection record concerns Unit Dose Services, LLC, with an inspection on April 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Christie A. Garcia (Issuing Officer)
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ID · 07216fb1-cd3d-4aa1-b4ae-eb628b89a562
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049791
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Unit Dose Services, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 19, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 8, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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