FDA Inspection
Sky Oxygen, Inc.Sky Oxygen, Inc. – FDA Inspection, Sep 16, 2010
Record Details
This FDA Inspection record concerns Sky Oxygen, Inc., with an inspection on September 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sky Oxygen, Inc.
- Inspection Date
- September 16, 2010
- Product Type
- Drugs
View Company Profile
ID · c8d9bd6d-7fcf-4938-95f7-bfb14f7ebba5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680271
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
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.