FDA Inspection
Oasis Medical, Inc.Oasis Medical, Inc. – FDA Inspection, Nov 16, 2018
Record Details
This FDA Inspection record concerns Oasis Medical, Inc., with an inspection on November 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · db10691c-bb3c-4292-879f-ef0ded881ac7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071867
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Oasis Medical, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2025 | OAI | Los Angeles District Office | Drug Quality Assurance |
| November 16, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 28, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Oasis Medical, Inc.
- FDA Inspection 1259656 - 2025-01-27
- FDA Inspection 1075290 - 2018-11-16
- FDA Inspection 1028717 - 2017-09-28
- FDA Inspection 941356 - 2015-08-28
- FDA Inspection 875200 - 2014-04-14
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