FDA Inspection
Unit Dose Services, LLCUnit Dose Services, LLC – FDA Inspection, Jan 31, 2020
Record Details
This FDA Inspection record concerns Unit Dose Services, LLC, with an inspection on January 31, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Unit Dose Services, LLC
- Inspection Date
- January 31, 2020
- Product Type
- Drugs
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ID · 08689cbb-a727-4c9d-adb6-b9581be46138
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1116418
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Unit Dose Services, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2018 | 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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