FDA Inspection
Essential Isotopes LlcEssential Isotopes Llc – FDA Inspection, Nov 17, 2017
Record Details
This FDA Inspection record concerns Essential Isotopes Llc, with an inspection on November 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a710eaf0-bc94-4bbb-9276-8775dd6425e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031558
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 212.100(a)Written complaint procedures
- 21 CFR 212.50(b)(7)Complete instructions, procedures, specs
- 21 CFR 212.60(f)Documenting procedures
- 21 CFR 212.60(g)(3)Complete record of all laboratory test data
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Essential Isotopes Llc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2026 | Not classified | Kansas City District Office | |
| June 15, 2017 | Not classified | Kansas City District Office | |
| January 8, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Essential Isotopes Llc
- FDA Inspection 1338530 - 2026-09-11
- FDA Inspection 1014942 - 2017-06-15
- FDA Inspection 861648 - 2014-01-08
- FDA Inspection 740765 - 2011-08-23
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