SriSai Biopharmaceutical Solutions LLC – FDA EIR, Jun 12, 2006

An initial FDA inspection was conducted at Srisai Biopharmaceutical Solutions LLC, a warehouse and distributor of human drugs, medical devices, and dietary supplements in Frederick, MD, as part of the FY [redacted] workplan. The specific inspection dates were redacted in the report. This comprehensive routine inspection focused on the firm's quality, materials, and facility/equipment systems related to human drug operations, and repacking/warehousing for dietary supplements, under relevant compliance programs. Medical device operations were not covered.

During the inspection, no FDA Form 483 (Inspectional Observations) was issued. However, three verbal observations were discussed with management. The main issues identified included the absence of a written product recall procedure, failure to provide Good Manufacturing Practices (GMP) training to two newly hired employees, and the lack of a specific Standard Operating Procedure (SOP) for the repacking of dietary supplements.

The company's President, Mr. Konduru, committed to correcting all identified deviations. Additionally, management was reminded of the upcoming re-registration requirement in July [redacted] and to update their registration status to include future service offerings. No samples were collected, and no refusals were encountered during the inspection.