FDA WARNING_LETTER - Access Bio, Inc. - August 31, 2010

On December 22, 2010, the FDA issued a Warning Letter to Access Bio, Inc. following an inspection from August 4-31, 2010, at their Somerset, New Jersey facility. The inspection revealed significant violations related to the manufacture and marketing of in vitro diagnostic (IVD) test kits, including CareStart HIV, Syphilis, Malaria, and HCV test kits.

The primary violations include: 1. **Unapproved Devices:** CareStart HIV test kits, classified as Class III devices, were marketed without premarket approval (PMA) or an investigational device exemption (IDE), rendering them adulterated under section 501(f)(1)(B) of the Act. CareStart Syphilis, Malaria, and HCV test kits were also offered for sale without marketing approval or clearance, making them adulterated and misbranded under section 502(o) for failure to submit 510(k) notifications. 2. **Quality System Regulation (QSR) Violations (21 CFR Part 820):** * **Device History Records (DHRs) (820.184):** Failure to maintain DHRs demonstrating manufacturing in accordance with the Device Master Record (DMR), including missing purchasing, production, nonconformity, rework, sterilization, verification, acceptance, and labeling records for multiple HIV test kit lots. Specific forms