FDA Inspection
Unit Dose Services, LLCUnit Dose Services, LLC – FDA Inspection, Jan 19, 2018
Record Details
This FDA Inspection record concerns Unit Dose Services, LLC, with an inspection on January 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Christie A. Garcia (Issuing Officer)
View Company Profile
ID · 47b005e0-46d1-49c7-bb50-1bc6b5bdab12
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038090
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
Full citation text and observation details available on the Dashboard.
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 |
| April 26, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 8, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Unit Dose Services, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.