Adept Medical Ltd – FDA Warning Letter, May 16, 2024

On October 11, 2024, the FDA issued a Warning Letter to Mr. Fenton of a firm in Auckland, New Zealand, following an inspection from May 13-16, 2024. The firm manufactures Tympanostomy Tubes, "NeoZoline Ventilation Tubes," which are classified as adulterated devices under 21 U.S.C. §351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain procedures for acceptance activities (21 CFR 820.80(a)):** Inadequate incoming inspection and acceptance procedures for Biological Indicators (BIs) and Sterile Potties. The firm discards Certificates of Conformance for BIs, fails to retain critical documents, does not perform BI Population verification tests, and lacks documentation of BI batch numbers and expiration dates on test reports. For sterile potties, the firm accepts lots without Certificates of Sterilization and performs no additional sterility testing. The firm's response was deemed inadequate as it did not provide evidence of corrections or a commitment to retrospectively assess affected devices. 2. **Failure to validate processes (21 CFR 820.75(a)):** The ultrasonic cleaning process and the (b)(4) process for NeoZoline Ventilation Tubes were not adequately validated. Critical