FDA 483 - Stratus BioSystems, LLC - June 11, 2024

Stratus BioSystems, LLC, an HCT/P manufacturer in Grapevine, TX, was subject to an FDA inspection from June 3 to June 11, 2024. The inspection resulted in a Form FDA 483, outlining a critical observation related to their manufacturing practices. The primary issue identified was the company's failure to establish, define, and document robust procedures for validating and approving processes that cannot be fully verified through inspection and tests alone. Specifically, Stratus BioSystems had not determined or documented an allowable hold time for its AmnioAMP-MP amniotic membrane product during the manufacturing sequence, particularly between the initial membrane processing and subsequent freezing and drying steps. Their existing process validation and standard operating procedures for manufacturing allograft membrane implants omitted details regarding this interim storage and its permissible duration. Consequently, the firm was applying a one-year expiration date to its product without properly validating these unaddressed hold periods. This observation signals a clear need for Stratus BioSystems, LLC, to address these deficiencies in their process validation and documentation to ensure product quality and adherence to regulatory expectations. The company is expected to respond to these findings by discussing objections or detailing proposed corrective actions.