# FDA 483 - Valisure, LLC - July 06, 2021

Source: https://www.keypedia.com/records/483/valisure-llc/d252bf67-5150-44d1-9249-b64e740eba01

> FDA 483 for Valisure, LLC on July 06, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valisure, LLC
- Inspection Date: 2021-07-06
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Valisure, LLC in New Haven, CT, an analytical lab, revealed significant deficiencies across multiple quality systems. The firm failed to adequately validate analytical methods, qualify equipment, control data access, and conduct proper laboratory investigations for out-of-specification events. Furthermore, Valisure demonstrated a critical lack of compliance with Drug Supply Chain Security Act requirements for handling suspect and illegitimate products and making timely notifications.

## Related Documents

- [EIR - 2021-07-06](https://www.keypedia.com/records/eir/valisure-llc/94c1f5af-40e9-4d43-b7ab-a030b2a0d423)
- [483 - 2021-07-06](https://www.keypedia.com/records/483/valisure-llc/1f3b1978-4257-48f4-ae57-da89343cebe1)

## Related Officers

- [Regulatory Counsel at Food and Drug Administration, Center for Drug Evaluation and Research](https://www.keypedia.com/people/sarah-e-venti/3cce2656-0c7f-4409-9915-94904c877997)
- [Regional Manager](https://www.keypedia.com/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)
- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.keypedia.com/companies/valisure-llc/0db0d42f-d9e5-4231-b8ec-5b205d97de84

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94