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# Oscor Cited for GMP Violations with 2 Devices
- URL: https://www.fdaweb.com/oscor-cited-for-gmp-violations-with-2-devices/
- Published: 2016-07-19T12:00:00.000Z
- Updated: 2026-09-14T21:15:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136218

FDA has sent Palm Harbor, FL-based Oscor Inc. a Warning Letter after an inspection cited GMP deficiencies involving the manufacturing of introducer catheters (Adelante Magnum) and a neuromodulator for obesity (Maestro Rechargeable System). According to the [letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm509968.htm?ref=fdaweb.com), Oscor failed to develop, conduct, control, and monitor production processes to ensure that their devices conform to specifications. For example, the agency says the firm uses a “Single Lot Release” for certain sterilization processing of the Maestro Rechargeable System, but this “does not provide assurance that sterility requirements for the device are met. While Single Lot Release may provide for release of product from a sterilization process where there is only sufficient product to make up a single sterilization load and without going through a full validation, the sterility assurance level (SAL) must be supported through specified test data. This is not evident from your firm’s process control records.”

The letter also cited Oscor for failing to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures. For example, it says, the “process verification documentation for the manufacture of the anterior and posterior leads of the Maestro Rechargeable System does not identify equipment operating parameters, to ensure that the process can consistently produce products meeting their specification. Specifically, your firm failed to validate or establish sufficient inspections or tests for the silicone injection over-molding process used for the electrodes of the anterior and posterior leads. Your firm implemented instructions to conduct 100% inspection of the finished leads and released the devices for distribution to your customer. Your 100% inspection is not sufficient as evident by your customer complaint indicating silicone flash/residue was found on the electrodes of the anterior and posterior leads and is associated with non-conformances of high impedance and loss of therapy from use of the Maestro Rechargeable System.”