FDA Inspection
Unit Dose Services, LLCUnit Dose Services, LLC – FDA Inspection, Nov 8, 2016
Record Details
This FDA Inspection record concerns Unit Dose Services, LLC, with an inspection on November 8, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0de789d9-2744-4c2b-a710-b99ecfe49be6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992993
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.170(b)Reserve drug product sample quantity - all tests
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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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 |
| 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 |
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