Recipient: Brymill Corporation
Product: liquid nitrogen cryosurgical devices
The inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act (21 U.S.C. 351 (h)), in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure of the design verification to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30 (f).
For example, review of the (b)(4) protocol found no raw data used to support the verification of the software used in the BryMill Tracker device.
FDA New England District Office