FDA WARNING_LETTER - Oridion Medical 1987 Ltd. - June 15, 2011

On October 4, 2011, the FDA issued a Warning Letter to Oridion Medical 1987 Ltd. following an inspection from June 12-15, 2011, at their Jerusalem, Israel facility. The inspection revealed that the firm's MicroStreamCO2 Filterline device was adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, due to non-conformity with current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain adequate procedures for purchased products and services (21 CFR 820.50):** Specifically, quality requirements were not established or maintained for their contract manufacturer, (b)(4), responsible for manufacturing, finished device testing, and Device History Records (DHRs). Neither Oridion nor (b)(4) could account for all units produced, and DHRs were not provided or demonstrated to be maintained. 2. **Inadequate quality controls for nonconforming product disposition:** For (b)(4) nonconforming units, disposition was documented with a retrospectively created Certificate of Destruction, lacking supporting production or acceptance records. Incomplete instructions were provided to (b)(4) for rework, with no requirements for documenting these activities in the DHR. The original lot