FDA Inspection
Promethean LifeSciences, Inc.Promethean LifeSciences, Inc. – FDA Inspection, Jan 11, 2013
Record Details
This FDA Inspection record concerns Promethean LifeSciences, Inc., with an inspection on January 11, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 11, 2013
- Product Type
- Biologics
View Company Profile
ID · 7416543a-49d1-4ede-bb3f-8932c849503d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 814566
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.190(d)(2)Documentation of activities
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.160(b)(5)Monitoring systems
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Promethean LifeSciences, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 9, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 28, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 7, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Promethean LifeSciences, Inc.
- FDA Inspection 1304480 - 2026-02-18
- FDA Inspection 1172008 - 2022-06-09
- FDA Inspection 1021850 - 2017-06-28
- FDA Inspection 962793 - 2016-03-07
- FDA Inspection 917223 - 2015-03-11
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