# FDA WARNING_LETTER - Reproductive Technologies, Inc. - August 16, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/reproductive-technologies-inc/a6488682-db96-45d7-8a7f-441586fe4d89

> FDA WARNING_LETTER for Reproductive Technologies, Inc. on August 16, 2019. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Reproductive Technologies, Inc.
- Inspection Date: 2019-08-16
- Product Type: Biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: On November 6, 2019, the FDA issued a Warning Letter to Reproductive Technologies, Inc. following an inspection from August 5-16, 2019. The inspection revealed significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include:
1.  **Failure to quarantine semen** from anonymous donors until required retesting was complete (21 CFR 1271.60(a)). Examples cited include semen distributed before the six-month retesting was performed.
2.  **Failure to test anonymous semen donors for West Nile Virus (WNV)** using an FDA-licensed NAT donor screening test at the time of first donation within the June-October testing period, and/or failure to retest at least six months post-donation (21 CFR 1271.80 and 1271.85(d)).
3.  **Failure to determine ineligible donors** with risk factors for communicable diseases (21 CFR 1271.75(d)(1)). Since March 2016, at least seven anonymous semen donors with a history of sex with other men in the preceding five years were deemed eligible.
4.  **Failure to perform complete donor screening procedures** (21 CFR 1271.7

## Related Documents

- [483 - 2019-08-16](https://www.globalkeysolutions.net/records/483/reproductive-technologies-inc/bee58ae9-e9bd-4050-81d0-da45f602ce72)
- [483 - 2024-11-18](https://www.globalkeysolutions.net/records/483/reproductive-technologies-inc/17dd402d-e532-4072-8270-7fee3c51c869)

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

Company: https://www.globalkeysolutions.net/companies/reproductive-technologies-inc/81a46c28-125d-4e9e-ba8b-1d521dff2b44

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1