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

Source: https://www.globalkeysolutions.net/records/warning_letter/kelyniam-global-inc/bcd10bd9-2316-472d-be4c-9873783e93c4

> FDA WARNING_LETTER for Kelyniam Global, Inc. on May 30, 2017. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Kelyniam Global, Inc.
- Inspection Date: 2017-05-30
- Product Type: Devices
- Office Name: New England District Office
- Summary: 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

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## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/joseph-s-matrisciano/62ff5cd6-c3ab-4443-bf26-f61a512f3960)

Company: https://www.globalkeysolutions.net/companies/kelyniam-global-inc/447b1f6a-d649-4aa2-9115-afbe99879688

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144