Bio Focus Co. Ltd. – FDA Warning Letter, Apr 17, 2013

On April 15-17, 2013, the FDA inspected Bio Focus Co. Ltd. in Uiwang-si, South Korea, and found their Sure-Aid brand pregnancy tests to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: In-process nonconformances for hCG test strips and Sure-Aid Pregnancy Tests did not trigger Corrective Action Requests, and nonconformances were not included in data analysis. The firm's response was inadequate, lacking clarity on revisions, follow-up, and retrospective analysis. 2. **Inadequate process validation (21 CFR 820.75(a))**: Validation of the Reel-to-Reel Dispenser, Model DAI-300, was incomplete. Acceptance criteria for IQ, OQ, and PQ were undefined, and OQ was not performed. The response was inadequate, lacking evidence of employee training and systemic review. 3. **Inadequate design validation, including risk analysis (21 CFR 820.30(g))**: The risk analysis for the Sure-Aid Pregnancy Test was not updated to include all