Progressive Medical Inc – FDA Warning Letter, Sep 1, 2011

On January 10, 2012, the FDA issued a Warning Letter to Progressive Medical, Inc. following an inspection from August 30 to September 1, 2011. The inspection determined that the firm manufactures various medical devices, including the MedPro AccuFlo Elastomeric Infusion Pump and Progressive Medical Disposable Uterine Manipulator, which are considered adulterated under Section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)). 2. Failure to establish and maintain design and development plans (21 CFR 820.30(b)), specifically lacking design plans for contract-manufactured products. 3. Failure to define control over suppliers and contractors (21 CFR 820.50(a)(2)), including no procedures for qualifying contractors, no documentation for manufacturer evaluation, and no approval of contract manufacturers. Medpro International also failed to obtain premarket clearance for AccuFlo and AccuRx pumps. 4. Failure to establish and maintain document control procedures (21 CFR 820.40), with several procedures lacking approval dates and/or signatures. 5. Failure of management to review