FDA Inspection
Eurofins CellTx IncEurofins CellTx Inc – FDA Inspection, Sep 20, 2024
Record Details
This FDA Inspection record concerns Eurofins CellTx Inc, with an inspection on September 20, 2024, issued by the Denver District Office, covering biologics.
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ID · 56f4b00b-2750-416f-9105-0d316ef02ffd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249766
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.190(d)(2)Documentation of activities
- 21 CFR 1271.210(c)In-house reagent production
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.200(a)Capable of valid results
- 21 CFR 1271.270(a)Accurate, indelible, legible
- 21 CFR 1271.270(a)Records maintained concurrently
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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