FDA WARNING_LETTER - Dongguan Microview Medical Technology Co., LTD - June 27, 2019

On September 20, 2019, the FDA issued a Warning Letter to a firm in Guangdong, China, following an inspection from June 24-27, 2019. The firm manufactures the MicroView Disposable Endoscopic Cannula, which are medical devices. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Violations include: 1. Failure to control nonconforming product (21 CFR 820.90(a)), evidenced by unlabeled nonconforming finished devices and subassemblies. 2. Failure to adequately validate processes (21 CFR 820.75(a)), specifically regarding ethylene oxide (EO) sterilization (lack of documented rationale for PCD/BI placement, sample size) and packaging processes (unvalidated pouch packaging, inconsistent sealing parameters). 3. Failure to revalidate processes after changes (21 CFR 820.75(c)), as the primary sealing packaging process was not revalidated after relocation. 4. Failure to verify effectiveness of corrective and preventive actions (CAPAs) (21 CFR 820.100(a)(4)), with two CAPAs (missing labels, unqualified supplier list)