| 2-3- General Requirements | - Deficiencies were noted related to general requirements outlined in the Safety of Sperm and Ova Regulations.
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| 4-21- Registration and Notification | - Deficiencies were noted with the establishment’s annual attestation.
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| 22-40- Donor Suitability | - Deficiencies were noted in the donor suitability assessment.
- Deficiencies were noted in donor screening and/or testing.
- Deficiencies were noted in the required quarantine of sperm or ova.
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| 41-85- Quality Management | - Deficiencies were noted in the establishment’s quality management system.
- Deficiencies were noted with the establishment’s standard operating procedures or internal audits.
- Deficiencies were noted in personnel qualifications or training.
- Deficiencies were noted with the establishment’s facilities, equipment or supplies.
- Deficiencies were noted with meeting the error and accident investigation or reporting requirements.
- Deficiencies were noted with meeting the adverse reaction investigation or reporting requirements.
- Deficiencies were noted with meeting the record requirements.
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