FDA Inspection
Oasis Medical, Inc.Oasis Medical, Inc. – FDA Inspection, Jun 26, 2012
Record Details
This FDA Inspection record concerns Oasis Medical, Inc., with an inspection on June 26, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Oasis Medical, Inc.
- Inspection Date
- June 26, 2012
- Product Type
- Drugs
View Company Profile
ID · 42e50763-afae-4112-8d12-5cba97ee6ce1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 788941
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.166(a)(3)Valid stability test methods
Full citation text and observation details available on the Dashboard.
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 |
| November 16, 2018 | VAI | 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 |
Other documents for Oasis Medical, Inc.
- FDA Inspection 1259656 - 2025-01-27
- FDA Inspection 1075290 - 2018-11-16
- FDA Inspection 1071867 - 2018-11-16
- FDA Inspection 1028717 - 2017-09-28
- FDA Inspection 941356 - 2015-08-28
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.