FDA WARNING_LETTER - Biomedix Wai - October 31, 2019

The FDA issued a Warning Letter to a medical device manufacturer following an inspection from October 21-31, 2019, which found their SELEC-3 gravity I.V. administration and extension sets to be adulterated. The firm's manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to control nonconforming product (21 CFR § 820.90):** Repeated observation from 2013. 233 out of 233 documented tests had uninvestigated anomalous results. Non-conforming product was not evaluated or investigated per procedures, with 11 of 13 reviewed device history records showing uninvestigated defects. The firm's responses were inadequate, lacking retrospective review and documentation of investigations. 2. **Failure to validate processes (21 CFR § 820.75(a)):** Repeated observation from 2013 and 2018. Process validations lacked seal integrity testing, used uncalibrated equipment for the full range, and did not use the required sample sizes or appropriate AQLs for high-risk failures. The firm's response was inadequate, requiring review of other validations and complete revalidation reports. 3. **Failure to monitor and control validated processes (21 CFR