FDA Inspection
Osteotech, Inc.Osteotech, Inc. – FDA Inspection, Dec 9, 2010
Record Details
This FDA Inspection record concerns Osteotech, Inc., with an inspection on December 9, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Osteotech, Inc.
- Inspection Date
- December 9, 2010
- Product Type
- Biologics
View Company Profile
ID · 9f6749e0-b853-4c18-aff4-5e53a09fd384
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699572
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(b)Documentation
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 1271.250(a)Controlling the labeling of HCT/Ps
- 21 CFR 1271.160(b)(5)Monitoring systems
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Osteotech, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 12, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 30, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 10, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 6, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Osteotech, Inc.
- FDA Inspection 1245789 - 2024-06-18
- FDA Inspection 1150237 - 2021-08-12
- FDA Inspection 1060874 - 2018-07-30
- FDA Inspection 1021037 - 2017-08-10
- FDA Inspection 925160 - 2015-05-06
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