FDA Inspection
Ortho Pros, Inc.Ortho Pros, Inc. – FDA Inspection, Oct 21, 2011
Record Details
This FDA Inspection record concerns Ortho Pros, Inc., with an inspection on October 21, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Ortho Pros, Inc.
- Inspection Date
- October 21, 2011
- Product Type
- Biologics
View Company Profile
ID · bfb31f64-ea88-4b8c-9f09-5a04a9b7fc5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752063
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.260(d)Corrective actions
- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Periodic review of temperatures
- 21 CFR 1271.265(c)(1)Release criteria verified, documented
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Ortho Pros, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2025 | Not classified | Denver District Office | |
| February 13, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 23, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 14, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Ortho Pros, Inc.
- FDA Inspection 1280986 - 2025-08-19
- FDA Inspection 1083581 - 2019-02-13
- FDA Inspection 959248 - 2016-02-23
- FDA Inspection 634422 - 2009-12-14
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