FDA Inspection
NuCel Lab IncNuCel Lab Inc – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns NuCel Lab Inc, with an inspection on March 16, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9456a39d-4c17-4e98-8fec-9327725a2ff8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011613
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of NuCel Lab Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2011 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for NuCel Lab Inc
- FDA Inspection 756210 - 2011-12-21
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