King Systems Corp. dba Ambu, Inc. – FDA Warning Letter, Aug 14, 2013

On September 30, 2013, the FDA issued a Warning Letter to King Systems Corp following an inspection from July 31 to August 14, 2013. The inspection revealed that the King Flex 2, King F2, King PedF2, and King F Breathing Circuits were adulterated because their manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to validate manufacturing processes (21 CFR 820.75(a)):** Specifically, the firm's (b)(4) used to produce tubing for breathing circuits were not validated. The validation of the Flex 2 Assembly Automation System for leak testing was inadequate, as it did not sufficiently document the size and location of holes in process challenge devices or study leak testing on collapsed tubing. The firm's proposed timeline for validation was deemed unacceptable. 2. **Failure to establish and maintain in-process product procedures (21 CFR 820.80(c)):** In-process occlusion testing of coaxial pediatric breathing circuits was not performed correctly, with an employee observed testing circuits too quickly, preventing accurate readings. 3. **Inadequate Complaint Handling Procedure (21 CFR 820.198(b) and (c)):** The firm's procedure failed to include steps for