Biosphere Medical S.A. – FDA 483, Jul 26, 1999

An FDA inspection of Biosphere Medical S.A., a medical device manufacturer in Louvres, France, from July 26-29, 1999, revealed significant quality system deficiencies. The firm failed to adequately validate sterilization processes for its Embospheres product and its packaging, and lacked proper procedures for environmental controls and design verification. Additionally, issues were noted in process validation documentation and the completeness and execution of quality audits.