# FDA WARNING_LETTER - Bio Focus Co. Ltd. - April 17, 2013

Source: https://www.keypedia.com/records/warning_letter/bio-focus-co-ltd/c8180f62-e7d2-4996-a4b4-cf9de95c2d8a

> FDA WARNING_LETTER for Bio Focus Co. Ltd. on April 17, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bio Focus Co. Ltd.
- Inspection Date: 2013-04-17
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

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Company: https://www.keypedia.com/companies/bio-focus-co-ltd/930b1b99-feb6-4403-9962-19074c37becd

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