FDA WARNING_LETTER - RI. MOS S.R.L. - March 29, 2012

On March 26-29, 2012, an FDA inspection of RI. MOS. S.R.L. in Mirandola, Italy, revealed that the firm's manufactured medical devices, including obstetric anesthesia sets and various reproductive health devices, were adulterated. The manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Incomplete process validation** for packaging, specifically inadequate post-sterilization package integrity evaluations (21 CFR 820.75(a)). 2. **Lack of procedures for monitoring and controlling process parameters** for validated processes (21 CFR 820.75(b)). 3. **Absence of established process control procedures** for production processes, such as a specific sealing operation procedure for new equipment (21 CFR 820.70(a)(1)). 4. **Inadequate control of environmental conditions** to protect components from contamination (21 CFR 820.70(c)). 5. **Failure to maintain adequate procedures for personnel health, cleanliness, and clothing** to prevent product contamination (21 CFR 820.70(d)). 6. **Insufficient procedures for product identification** during all stages, leading to unidentified finished devices (21 CFR 820.60). 7