FDA Inspection 1078664 — Neva Analytics, LLC
The FDA completed an inspection of Neva Analytics, LLC on Feb 6, 2019 in Longmont, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 6, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Longmont, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |