FDA EIR - BioConvergence LLC - June 29, 2010

An FDA Good Manufacturing Practices (GMP) inspection was conducted at BioConvergence LLC in Bloomington, IN, from June 15 to June 29, 2010. This was a follow-up inspection directed by CDER, prompted by a confidential concern regarding potential impurities in clinical batches of Type V Collagen. The inspection, carried out under compliance program 7356.002, covered quality, materials, and facilities and equipment systems. Notably, no FDA-483 form was issued, indicating no official objectionable conditions requiring formal citations. However, three verbal discussion items were raised with management. First, pooling condensate was observed at the entry door of a cold room in the hazardous/volatile storage area. Management agreed to increase cleaning frequency during humid months to prevent microbial growth. Second, an internal material status in the electronic inventory system incorrectly displayed "QOH" (quality internal facility release) instead of "QC" (quarantine) for a pharmaceutical product lot. The firm identified this oversight before FDA review and committed to counseling the involved staff. Third, while temperature sensor calibrations were up-to-date, the Standard Operating Procedure (SOP) lacked the specific numerical range values for calibration and operational accuracy. BioConvergence agreed to update their calibration module and SOP to include these crucial values. These discussions highlight the firm's commitment to continuous improvement in quality systems, material control, and equipment management within the pharmaceutical warehousing and clinical material development framework.