FDA Inspection
telaGen, LLCtelaGen, LLC – FDA Inspection, May 11, 2016
Record Details
This FDA Inspection record concerns telaGen, LLC, with an inspection on May 11, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- telaGen, LLC
- Inspection Date
- May 11, 2016
- Product Type
- Biologics
View Company Profile
ID · 01f97d6d-ea1d-480a-87e1-149eebf18783
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 972643
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
Full citation text and observation details available on the Dashboard.
Other FDA inspections of telaGen, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for telaGen, LLC
- FDA Inspection 1051843 - 2018-04-30
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