FDA Inspection
Sharp Clinical Services, LLCSharp Clinical Services, LLC – FDA Inspection, Aug 30, 2019
Record Details
This FDA Inspection record concerns Sharp Clinical Services, LLC, with an inspection on August 30, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9704a456-22f2-4a21-b8c3-5901eee894c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100829
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Sharp Clinical Services, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 2, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 27, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 14, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sharp Clinical Services, LLC
- FDA Inspection 1250631 - 2024-08-29
- FDA Inspection 1178811 - 2022-09-02
- FDA Inspection 943430 - 2015-08-27
- FDA Inspection 777901 - 2012-04-20
- FDA Inspection 582359 - 2009-04-14
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