RD Medical Manufacturing, Inc. – FDA Warning Letter, Nov 18, 2010

An FDA inspection of RD Medical Manufacturing Holding Company in Las Piedras, Puerto Rico, from October 6 to November 18, 2010, found that their Class I and Class II convenience kits and IV sets were adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to fully review, evaluate, and investigate complaints (21 CFR § 820.198(c))**: The firm did not adequately investigate a complaint regarding "Y-sites glue upside down" in Lot LYE023 and Lot LYG004. The investigation failed to extend to other lots, evaluate process controls, or analyze risks. The firm's response was inadequate, lacking evidence for inspection results, new distributor information, and justification for not investigating Lot LYG004. A discrepancy was noted between the firm's conclusion that the defect did not affect functionality and its FMEA, which stated it made the device unusable. 2. **Failure to document personnel training (21 CFR § 820.25(b))**: The firm lacked documentation showing operators performing specific techniques were certified, despite these techniques being identified as root causes for product failures in prior investigations. The firm's response was inadequate, lacking evidence of training for these specific techniques and interim