FDA WARNING_LETTER - Kelyniam Global, Inc. - May 30, 2017

On October 5, 2017, the FDA issued a Warning Letter to Kelyniam Global, Inc. following an inspection from May 10-30, 2017. The inspection revealed that the firm's patient-specific cranial and maxillofacial implants are adulterated under 21 U.S.C. § 351(h) because their manufacturing processes do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain design change procedures (21 CFR 820.30(i))**: Significant design changes, such as the Temporal Suture System (TSS) and Integrated Fixation System, lacked design validation. Labeling changes were also not promptly updated. 2. **Failure to evaluate complaints for MDR reportability (21 CFR 820.198(a)(3))**: The firm failed to investigate re-orders, including one involving a patient infection, and did not consistently evaluate complaints for injury, death, infection, or extended surgery. 3. **Failure to manufacture devices in accordance with the device master record (21 CFR 820.184)**: Device History Records (DHRs) lacked documentation of required testing. 4. **Failure to validate processes (21 CFR 820.75