FDA WARNING_LETTER - GeoTec, Inc. - August 24, 2015

The FDA issued a Warning Letter to GeoTec, Inc. following an inspection from August 11-24, 2015, which found their radio frequency cannulated (RFC) electrodes and laparoscopic cannulas and trocars to be adulterated. The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Significant violations included: 1. **Failure to adequately validate processes (21 CFR 820.75(a))**: The Banyan Cannula and Trocar Packs were not adequately validated. Deficiencies in validation reports included lack of approved protocols with accepted specifications, inconsistent data versions (one showing failing results, another omitting them without explanation), unjustified differences in tested samples (quantities, lengths, sideports, sterilization, aging), lack of result comparisons, and missing incoming inspection reports. A required real-time aging study for Banyan Medical Cannula/Trocars had not been initiated. The firm's response was inadequate, lacking documentation of appropriate validation and real-time stability testing. 2. **Failure to maintain adequate device history records (DHRs) (21 CFR 820.184)**: Rework documentation for lot M0070815-21 was not recorded in the DHR. Operations were recorded as performed before subassemblies were released (e.g., lots