Bioland Technology Ltd. – FDA Warning Letter, Mar 20, 2014

The FDA issued a Warning Letter to Bioland Technology Ltd. following an inspection from March 17-20, 2014, concerning their Clever Choice Blood Glucose Monitoring System. The inspection found the devices 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 USC 352(t)(2) for failing to comply with Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Key QS violations included: failure to validate processes (21 CFR 820.75(a)), inadequate process control procedures (21 CFR 820.70(a)) such as handling dropped components, insufficient environmental controls for Electro-Static Discharge (ESD) (21 CFR 820.70(c)), and failure to maintain complete Device History Records (DHRs) (21 CFR 820.184). Additionally, the firm failed to develop and implement adequate written MDR procedures (21 CFR 803.17(a)(2)), lacking a standardized review process for reportable events.

The firm's April 3, 2014 response was deemed inadequate, as it lacked documentation of systemic corrective actions, retrospective reviews, and employee training. Bioland Technology Ltd. must provide a written response within fifteen business days detailing specific corrective actions, including systemic changes, prevention plans, and a timetable. Failure to correct these violations could impact federal contracts and prevent premarket approval for Class III devices. A re-inspection may be necessary to verify compliance.