FDA WARNING_LETTER - CASMED International, Ltd. - August 16, 2012

On August 15-16, 2012, an FDA inspection of CASMED International, Ltd. in Surrey, UK, revealed that their Oocyte Aspiration Needles, Procedure Needles, Camera Covers, Needle Guides, Trocars and Cannulas, and Tubing Sets are adulterated. The manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a)):** The (b)(4) sterilization process for Assisted Reproduction Needles was not validated. CASMED stated the contract sterilizer no longer exists and revalidation would take (b)(4) weeks. 2. **Failure to establish design control procedures (21 CFR 820.30(a)):** No design control procedures were in place for devices like Oocyte Aspiration Needles. CASMED indicated they would submit a procedure in (b)(4) weeks. 3. **Failure to control labeling activities (21 CFR 820.120):** The labeling work instruction lacked a requirement for labeling inspection, and no labeling procedure existed for Assisted Reproduction Needles. CASMED's response, including revised work instructions incorporating labeling inspections, appears adequate. 4. **Failure to maintain Device History Records (DHRs) (