# FDA 483 - Northeastern Reproductive Medicine PLLC - August 16, 2019

Source: https://www.globalkeysolutions.net/records/483/northeastern-reproductive-medicine-pllc/dc83ec30-69a8-4e65-9022-8cbdacc5d017

> FDA 483 for Northeastern Reproductive Medicine PLLC on August 16, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northeastern Reproductive Medicine PLLC
- Inspection Date: 2019-08-16
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: Northeastern Reproductive Medicine PLLC in Colchester, VT, a reproductive HCT/P establishment, was cited for two observations related to donor screening. The firm failed to adequately screen donors for communicable disease agents, including Zika virus (ZIKV), and lacked defined procedures for donor eligibility determination. This indicates deficiencies in their donor screening processes and associated documentation.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/alice-silva/b4b46db5-2b1a-452c-a403-9265a8785330)

Company: https://www.globalkeysolutions.net/companies/northeastern-reproductive-medicine-pllc/f2f3e4ab-8b12-4e5b-8988-25043af95c32

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