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

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