FDA WARNING_LETTER - Arriol International Corp. - April 12, 2012

On April 9-12, 2012, an FDA inspection of Arriol International Corp. in Santo Domingo, Dominican Republic, found that their EZ IO intra osseous injection system and aseptic transfer kits for breast implants were adulterated. The firm's manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to analyze quality data (21 CFR 820.100(a)(1)):** Nonconforming product data was not adequately analyzed for trends, and no investigations were initiated despite approximately (b)(4) nonconformances in 2012. The firm's response, including a Spanish procedure, was deemed inadequate as it lacked evidence of corrections or systemic actions. 2. **Failure to validate processes (21 CFR 820.75(a)):** The (b)(4) sterilization process validation did not establish actual (b)(4) levels until (b)(4) after processing, failing to demonstrate adequate (b)(4) removal. The firm's response, proposing an (b)(4) dissipation curve, was inadequate due to lack of documentation and a systemic corrective action plan. 3. **Failure to control production processes (21 CFR 820.70(a)):** The (b)(4) sterilization