FDA 483 - New York Blood Center Enterprises - January 16, 2018

The FDA issued a Form 483 to New York Blood Center, Inc. in Melville, NY, following an inspection of their Donor Center. The inspection revealed deficiencies related to equipment performance, specifically the use of a non-calibrated scale for blood collection, and a failure to maintain adequate quality control and general records, including a lack of documented staff training for donor weight scales. These issues indicate a need for improved adherence to established procedures and record-keeping practices.