FDA Inspection
Oklahoma Respiratory Care, Inc.Oklahoma Respiratory Care, Inc. – FDA Inspection, Oct 28, 2011
Record Details
This FDA Inspection record concerns Oklahoma Respiratory Care, Inc., with an inspection on October 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 28, 2011
- Product Type
- Drugs
View Company Profile
ID · 248025b7-c031-4585-aca9-73163e4586d0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 752449
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oklahoma Respiratory Care, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Oklahoma Respiratory Care, Inc.
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.