FDA WARNING_LETTER - Superior Products, Inc. - October 31, 2007

On October 17-31, 2007, an FDA inspection of Superior Products, Inc. in Cleveland, OH, revealed that the firm's medical devices, including oxygen conservers and regulators, were adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. Failure to identify all actions needed to correct and prevent recurrence of nonconforming product (21 CFR § 820.100(a)(3)), specifically regarding leaks in Oxy-Serve II oxygen conserving regulators, where a recall was only initiated during the inspection despite prior knowledge. 2. Failure to review, evaluate, and investigate complaints (21 CFR § 820.198(c)) for at least 10 Oxy-Serve II complaints. 3. Failure to verify or validate corrective and preventive actions (21 CFR § 820.100(a)(4)), specifically design changes to the Oxy-Serve II. The firm's response was inadequate, lacking documented validation evidence. 4. Failure to implement nonconforming product procedures (21 CFR § 820.90(a)), with nonconforming products observed unisolated. The response was inadequate, lacking revised manufacturing procedures. 5. Failure to assure design