FDA Inspection
Organogenesis, Inc.Organogenesis, Inc. – FDA Inspection, Jun 13, 2014
Record Details
This FDA Inspection record concerns Organogenesis, Inc., with an inspection on June 13, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Organogenesis, Inc.
- Inspection Date
- June 13, 2014
- Product Type
- Biologics
View Company Profile
ID · 8d082826-9c5e-42fb-9ef4-0178be66db59
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 879597
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Organogenesis, Inc.
15| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2025 | Not classified | New England District Office | |
| December 1, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 8, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 26, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Organogenesis, Inc.
- FDA Inspection 1273250 - 2025-08-29
- FDA Inspection 1158368 - 2021-12-01
- FDA Inspection 1055007 - 2018-06-08
- FDA Inspection 1050416 - 2018-04-26
- FDA Inspection 1014830 - 2017-05-26
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