FDA Warns O2 Devicemaker on Product Failures, Procedures
The FDA has handed Inovo a warning letter for failing to correct, or in some cases document, faulty procedures and fixes to device defects.
Inovo, which makes oxygen products for the home use market, failed to determine the cause or take adequate action regarding complaints about pulse malfunctions in its Evolution, SmartDose and Part 6505 pneumatic oxygen conservers, according to the Feb. 19 letter posted online recently.
After the company documented that an incoming shipment of these switches failed sensitivity testing, and the supplier agreed to use a pneumatic press to alleviate the problem, Inovo amended its procedure, but didn’t document the effectiveness of this action, the FDA says.
Testing and Protocols
The agency also cites Inovo for failing to establish and maintain procedures for developing and validating device software design. Specifically, documentation for the Evolution conserver doesn’t include structural testing at the code level or an adequate description of regression testing, the warning letter says.
In addition, clinical documentation for the Evolution conserver doesn’t include the written protocol or patient’s baseline saturation levels for the 900M model or device settings for the patients. The letter also dings Inovo for lacking procedures to ensure that all products and services conform to specifications.
In yet another GMP violation, the firm’s supplier procedures don’t require written evidence of critical controls for manual processes, and there is no plan for possible requalification of suppliers, the letter says. Further, Inovo’s risk hazard analysis for the OM-900 series oxygen conserver fails to identify risk factors for inadequate pulsing, including defective inhalation switches, piezo valves and printed circuit boards, as well as effective remedies for the problem.
Inovo’s responses were too slow given the seriousness of the deficiencies, the letter says.
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