Biosafe Laboratories – FDA Warning Letter, Jun 2, 2008

On May 15-June 2, 2008, an FDA inspection of Biosafe Laboratories in Chicago, IL, revealed that their Anemia meter and blood specimen collection systems for C-Reactive Protein, Age-Mediated Asthma Panel, and Prostate Test (PSA), along with other in-vitro diagnostic tests, are adulterated. The firm's manufacturing, packing, storage, or installation methods and controls do not conform to current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Inadequate Quality System (21 CFR 820.20):** Lack of a quality plan, insufficient design history records, undocumented corrective and preventive actions, and inadequate complaint handling procedures. 2. **Lack of Quality Organizational Structure (21 CFR 820.20(b)):** The Director of QA/RA position has been vacant since July 2007. 3. **No Quality Plan (21 CFR 820.20(d)):** SOPs are limited to laboratory operations and do not cover management controls, CAPA, or nonconformance. 4. **No Management Review Procedures (21 CFR 820.20(c)):** No procedure for performing management reviews of the quality system. 5. **No Quality Audit Procedures