FDA Inspection
Neva Analytics, LLCNeva Analytics, LLC – FDA Inspection, Feb 6, 2019
Record Details
This FDA Inspection record concerns Neva Analytics, LLC, with an inspection on February 6, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b84a0f58-ac3c-4c38-9539-2a25e44dd3fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078664
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
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Other FDA inspections of Neva Analytics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2026 | Not classified | Denver District Office | Drug Quality Assurance |
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