# FDA 483 - Neva Analytics, LLC - February 06, 2019

Source: https://www.globalkeysolutions.net/records/483/neva-analytics-llc/ad68751d-8a40-4f26-8692-2d129a16fc99

> FDA 483 for Neva Analytics, LLC on February 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neva Analytics, LLC
- Inspection Date: 2019-02-06
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Next Analytics, LLC, a contract testing laboratory in Longmont, CO, revealed significant deficiencies in their quality systems. Observations included a lack of validation for computerized systems and equipment, inadequate laboratory controls with no formal Out of Specification (OOS) investigation procedure, and insufficient controls over computer systems allowing data deletion and lacking backup procedures. Additionally, the firm failed to establish formal procedures for handling drug product complaints.

## Related Officers

- [Food and Nutration Service ](https://www.globalkeysolutions.net/people/farhana-khan/2388f1b3-b96c-4ae9-a520-d469ef762ce9)

Company: https://www.globalkeysolutions.net/companies/neva-analytics-llc/8994d34f-9bda-4d86-bb1a-0983e5c04843

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face