# FDA WARNING_LETTER - The Centre for Reproductive Medicine - June 21, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/the-centre-for-reproductive-medicine/84f3a338-48d3-4fa3-b9f4-2c6fd0fadb42

> FDA WARNING_LETTER for The Centre for Reproductive Medicine on June 21, 2013. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Centre for Reproductive Medicine
- Inspection Date: 2013-06-21
- Product Type: Biologics
- Office Name: Dallas District Office
- Summary: The FDA conducted an inspection of The Centre for Reproductive Medicine from June 14-21, 2013, documenting significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include:
1.  **Failure to test donor specimens for communicable diseases:** Directed oocyte donor MRN # (b)(6) (Dec 5, 2012) was not tested for HIV-1/2, Hepatitis B Surface Ag, Hepatitis B Core, HCV, Treponema palladium, Chlamydia trachomatis, and Neisseria gonorrhea.
2.  **Failure to collect donor specimens within the required timeframe:** Anonymous oocyte donor # (b)(6) (Oct 11, 2012 recovery) had samples collected on Aug 13, 2012, exceeding the 30-day pre-recovery or 7-day post-recovery window.
3.  **Failure to screen donors with complete medical records:** Multiple anonymous and directed oocyte donors lacked complete physical exams or medical histories (e.g., anonymous donor # (b)(6) for July 18, 2012 recovery; directed donor MRN # (b)(6) for Dec 5, 2012 recovery).
4.  **Failure to make and document donor

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)

Company: https://www.globalkeysolutions.net/companies/the-centre-for-reproductive-medicine/d1e263df-7de8-44f2-93a0-5e521dabf352

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9