FDA WARNING_LETTER - MANDELAY KFT - October 17, 2019

On February 3, 2020, the FDA issued a Warning Letter to Pest Gyartelep Hrsz 12001/33, following an inspection from October 14-17, 2019, at their Tokol, Hungary facility. The inspection revealed that the firm's Scientific Consciousness Interface Operation (SCIO) System and Quantum University Energetic System Technology 9 (Quest 9) devices are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain adequate design control procedures (21 CFR 820.30):** Design validation for the Quest 9 device was inadequate, lacking full execution in real/simulated environments and proper documentation of defects and corrections. Design verification of hardware requirements was also not documented, and software changes were not verified prior to implementation. The firm's responses did not address this. 2. **Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a)):** Software-related complaints were handled via telephone and not documented or investigated as per the Quality Manual. The firm's responses did not address this. 3. **Failure to establish and