FDA WARNING_LETTER - Circulatory Technology, Inc. - September 26, 2018

On January 28, 2019, the FDA issued a Warning Letter to Circulatory Technology, Inc. following an inspection from August 22, 2018, to September 26, 2018, at their Oyster Bay, NY facility. The inspection determined that the firm is a specification developer for the Better Bladder and Bigger Better Bladder medical devices.

The devices were found to be adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820). The firm's October 22, 2018, response to the FDA 483 was deemed inadequate.

Violations included: 1. **Failure to perform and document revalidation activities (21 CFR 820.75(c))**: The firm added an assembly step in February 2018 to the Better Bladder manufacturing process but did not revalidate it. The firm's argument that a leak test and lack of complaints suffice was rejected. 2. **Failure to establish and maintain design control procedures (21 CFR 820.30(a))**: The February 2018 manufacturing change was not reviewed as part of design control. The firm's assertion that it wasn't a design change was deemed inadequate