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

Source: https://www.keypedia.com/records/eir/valisure-llc/34514c84-82ac-4109-b144-24b9a97d6bae

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

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## Details

- Record Type: EIR
- Company Name: Valisure, LLC
- Inspection Date: 2021-07-06
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Valisure, LLC, a contract testing laboratory in New Haven, CT, was conducted from May 26 to July 6, 2021. The "for-cause" inspection focused on assessing the firm's compliance with Current Good Manufacturing Practices (CGMP) under the FD&C Act, specifically section 501(a)(2)(B), and wholesaler distribution operations under the Drug Supply Chain Security Act (DSCSA).

The inspection revealed six significant deficiencies, documented on an FDA Form 483. Main violations included the failure to adequately validate or verify analytical methods for drug product testing, such as elemental impurities, nitrosamines, and dosage. The firm also lacked an adequate equipment qualification program, did not maintain proper control over electronic data, and had no formalized written process for investigating out-of-specification results. Furthermore, Valisure, LLC was cited for not having the verification systems required by the DSCSA and for lacking procedures to notify trading partners or the FDA about illegitimate products. Verbally discussed issues included insufficient employee training documentation and an absent change management system. The company's management maintained they primarily comply with ISO standards, not CGMP. Corrective actions are required to address these critical regulatory and quality system gaps.

## Related Documents

- [483 - 2021-07-06](https://www.keypedia.com/records/483/valisure-llc/d252bf67-5150-44d1-9249-b64e740eba01)
- [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

- [company_representative](https://www.keypedia.com/people/wolfgang-hinz/27bb3d17-83bd-4090-ab15-0871211b8032)
- [company_representative](https://www.keypedia.com/people/kaury-kucera/2dd83fe6-0798-444d-9a2e-6be0e53afc2d)
- [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/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144