# FDA 483 - The Laboratory at the Center for Advanced Reproductive Svcs - February 15, 2022

Source: https://www.globalkeysolutions.net/records/483/the-laboratory-at-the-center-for-advanced-reproductive-svcs/61fbc915-93da-420f-8ba1-ae5523e0d591

> FDA 483 for The Laboratory at the Center for Advanced Reproductive Svcs on February 15, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Laboratory at the Center for Advanced Reproductive Svcs
- Inspection Date: 2022-02-15
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: The FDA issued a Form 483 to The Laboratory at the Center for Advanced Reproductive Svcs in Farmington, CT, following an inspection from February 8-15, 2022. The inspection revealed a significant deficiency in donor screening practices, specifically concerning the incomplete or missing Zika Virus questions on their "Gamete Provider Medical History Interview Questionnaire" for oocyte and semen donors. This indicates a failure to adequately screen for communicable disease agents and diseases.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)

Company: https://www.globalkeysolutions.net/companies/the-laboratory-at-the-center-for-advanced-reproductive-svcs/5e2fa3e5-b0e3-42f6-8342-235ed8bfae3e

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7