483
Lifesouth Community Blood Centers - Montgomery RegionLifesouth Community Blood Centers - Montgomery Region – FDA 483, Apr 14, 2025
Record Details
Lifesouth Community Blood Centers - Montgomery Region was inspected and cited for significant deficiencies in phlebotomy site preparation, investigation of ABO blood grouping discrepancies, and quality control procedures for supplies and reagents. The observations indicate a lack of adherence to manufacturer instructions, internal SOPs, and federal regulations, potentially impacting the sterility of blood products and accuracy of blood typing.
- Inspection date
- April 14, 2025
- Product type
- biologics
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ID · 0c870d1b-7d82-4b88-806b-dc3379e67213
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