FDA WARNING_LETTER - Orthotics & Prosthetics One Inc - December 01, 2011

On November 29-December 1, 2011, an FDA inspection of Orthotics & Prosthetics One Inc. in Waterloo, IA, identified significant violations of the Quality System (QS) regulation for medical devices. The firm manufactures lower limb prosthetics, classified as Class II medical devices (21 CFR 890.3500), which are exempt from premarket notification but subject to current good manufacturing practice (CGMP) requirements (21 CFR Part 820).

The inspection revealed that the devices are adulterated under section 501(h) of the Act due to non-conformity with CGMP. Specific violations include: 1. Failure to establish a quality plan (21 CFR 820.20(d)). 2. Failure to establish quality system procedures and instructions (21 CFR 820.20(e)). 3. Failure to establish a quality policy and quality objectives (21 CFR 820.20(e)). 4. Failure to perform quality audits (21 CFR 820.22). 5. Failure to establish procedures for purchased/received product and service conformity (21 CFR 820.50). 6. Failure to establish a device master record (21 CFR 820.181). 7. Failure to establish design plans (21 CFR 82