FDA Inspection
BreathCo International Inc (dba AllGraft)BreathCo International Inc (dba AllGraft) – FDA Inspection, Jun 25, 2014
Record Details
This FDA Inspection record concerns BreathCo International Inc (dba AllGraft), with an inspection on June 25, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 25, 2014
- Product Type
- Biologics
View Company Profile
ID · 4a04772a-b7ef-49ad-bc60-4b4621190fa5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 884660
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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