Cellestis Inc – FDA Warning Letter, Mar 25, 2015

On August 26, 2015, the FDA issued a Warning Letter to Cellestis Inc. following an inspection from March 17-25, 2015, at their Santa Clarita, California facility. The inspection revealed that the firm's QuantiFERON-TB Gold (QFT) test device is adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting) and 21 CFR Part 806 (Corrections and Removals).

Key violations include: 1. **Failure to establish complaint handling procedures (21 CFR 820.198(a))**: Six Medical Device Reports (MDRs) referencing device deficiencies were not processed per requirements. Cellestis' response to revise quality agreements and procedures was deemed inadequate as verification of completion was lacking. 2. **Failure to adequately develop and implement MDR procedures (21 CFR 803.17)**: The "Advisory Notices" SOP 033