FDA Inspection
OSS MedicalOSS Medical – FDA Inspection, Oct 16, 2009
Record Details
This FDA Inspection record concerns OSS Medical, with an inspection on October 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OSS Medical
- Inspection Date
- October 16, 2009
- Product Type
- Biologics
View Company Profile
ID · 0cd33d03-7f57-42a9-98a8-1fdbd3766b37
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 620290
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.170(b)Qualifications lacking
- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.160(b)(2)Procedures for complaints and other information
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OSS Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 9, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for OSS Medical
- FDA Inspection 802578 - 2012-10-09
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.