FDA Inspection
KDNA Life Sciences LLCKDNA Life Sciences LLC – FDA Inspection, Feb 1, 2013
Record Details
This FDA Inspection record concerns KDNA Life Sciences LLC, with an inspection on February 1, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- KDNA Life Sciences LLC
- Inspection Date
- February 1, 2013
- Product Type
- Biologics
View Company Profile
ID · 60f6ebaf-cfb0-4123-9ac7-b63864ec8b3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816876
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.350(a)(1)Adverse reaction reporting to FDA
- 21 CFR 1271.160(b)(3)Actions verified, short and long term solutions
- 21 CFR 1271.190(b)(1)Clean, sanitary, orderly manner
- 21 CFR 1271.350(b)(2)Deviations not reported to FDA
- 21 CFR 1271.190(c)Control system
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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Other FDA inspections of KDNA Life Sciences LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 24, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for KDNA Life Sciences LLC
- FDA Inspection 1218897 - 2023-09-15
- FDA Inspection 668816 - 2010-06-24
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